Advance Pharmaceutical Issues Nationwide Voluntary recall of one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets
FOR IMMEDIATE RELEASE - January 17, 2013 - Advance Pharmaceutical Inc. today announced that it is conducting a voluntary nationwide recall of one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate. Advance Pharmaceutical Inc. initiated the recall on December 28, 2012 because they received a pharmacist complaint that a bottle of Ferrous Sulfate Tablets, 325 mg 07-2014, contained Meclizine HCl 25 mg tablets, NDC 0536-3990-01. Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with imprinted kidney or liver function, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.
Consumers who take three tablets daily of the defective product for treatment of iron deficiency will would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alterness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source : FDA
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Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A
Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected. Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.
Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.
Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and will issue recall communications to all physicians and other customers involved.
Source : FDA 2/05/2011
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Particles, odors again drive recalls, but origins differ
Cancer treatments, among the highest ranking of drugs in short supply, are now suffering a plague of recalls. Three of the extreme actions were announced last week, triggered by problems that sound similar to those of recent recalls. But last week's actions have largely different origins.
First, Roche's Genentech unit is battling a mothball-like odor and taste in bottled Xeloda tablets. The drugmaker has traced the odor to naphthalene and 1,4-dichlorobenzene. Unlike several high-visibility recalls by J&J's McNeil unit and other drugmakers, consumers are not describing the odor as "musty" or "moldy." And the chemical agent is a disinfectant and pesticide, not an insecticide used on wooden shipping pallets.
To maintain the drug supply, Genentech has arranged with the FDA to temporarily import the drug in blister packs from the UK.
Meanwhile, APP Pharmaceuticals is recalling five lots of colorectal-cancer treatment Irinotecan hydrochloride injection because of foreign material and non-sterility in one lot. Three customers reported the particle contamination. In contrast to recent particle-contamination recalls of injectables traced to glass delamination, the APP contaminant is fungal.
Finally, a mislabeling case involves Pfizer's prostate drug, Finasteride, which may be identified on the bottle as Citalopram (and vice-versa). Cancer sufferers might benefit from the antidepressant, but it's unlikely to cure them. The recall extends to consumers. And it's similar to a recent Mylan recall in which labels for two drugs were co-mingled.
Source ; Fierce Pharma
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Label-error recalls highlight weak link
The recent rash of labeling-error recalls begs the question of how this fundamental process step can repeatedly cause such costly actions, not to mention the danger to patients. Well-known names are associated with recent recalls: Pfizer/Greenstone's cancer/antidepressant drug mix-up in late March; Upsher-Smith's 3- vs. 10-mg Jantoven warfarin snafu; and Qualitest's phenobarbital/hydrocodone-acetaminophen juxtaposition.
Pfizer says only that incorrect labels were placed on bottles by a contractor. Upsher-Smith cites an "isolated incident" and said in its February recall notice it had already taken corrective measures. Qualitest says that some lots of both the hydrocodone/acetaminophen tablets and the phenobarbital used the same stock inventory of labels.
Upsher-Smith's "isolated incident" likely implies human error, says Trevor Richardson, VP at pharma label printing specialist HP Mile, in a phone interview. "There can be little difference among the labels for different doses of the same product, and there's lots of information on those labels." The numeral specifying dosage might be the only difference on busy-looking labels.
Ways to minimize the likelihood of such errors, he says, include shorter print runs for labels, use of a label-on-demand system, and use of 2D barcodes and a scanner for product verification on the filling line. All involve extra cost, of course, but have clear QC benefits.
A 2D barcode verification system might also have precluded Qualitest's label stock issue, says Richardson. A full-line clearance between labeling jobs might have, too. The full-line clearance yields a higher waste factor, but "it's SOP in our building, based on GMP requirements."
Source : Fierce Pharma
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Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling
Greenstone LLC announced a recall of medicines with lot number FI0510058-A on the label. Bottles labeled as Citalopram (used to treat depression) may contain Finasteride (used for the treatment of benign prostatic hyperplasia). Women who are, or may become pregnant, should not take or handle Finasteride due to the possible risk of side effects which may cause abnormalities to the external genitalia of a developing male fetus. Citalopram is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or pimozide; it is also contraindicated in patients with a hypersensitivity to Citalopram or any of the inactive ingredients in the tablet. Patients who discontinue Citalopram abruptly by inadvertently taking the mislabeled product may experience discontinuation symptoms and/or worsening of depression.BACKGROUND: This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. market. The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer.
RECOMMENDATION: Bottles of either Citalopram or Finasteride with lot number FI050058-A should be returned. Patients who believe they may have ingested the wrong medication should contact their physician as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
- Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Source : FDA (March 2011)
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J&J Draws More U.S. Scrutiny on Charges of Violating Laws in Drug Recalls
Johnson and Johnson (JNJ) the world’s biggest health products maker, will face more scrutiny from U.S. regulators after its McNeil unit was charged with violating federal laws following multiple recalls in the past year of over-the-counter drugs such as Tylenol. The Food and Drug Administration and Justice Department signed a consent decree yesterday with McNeil that requires the company to fix deficiencies at a plant in Fort Washington, Pennsylvania, that has been closed since April 30. McNeil must also address manufacturing violations at facilities in Lancaster, Pennsylvania, and Las Piedras, Puerto Rico, under “a strict timetable,” the agency said in a statement.
The legal agreement intensifies regulatory pressure on J&J to fix manufacturing woes that have led to dozens of recalled products and last year cost the world’s largest health-products company $900 million in sales. The FDA ordered McNeil to hire a quality-control expert and take steps to address the problems. Failure may result in fines of as much as $10 million annually.
“Now that the FDA is there, it’s going to make things worse,” said Les Funtleyder, a health-care portfolio manager at Miller Tabak & Co. in New York, in a telephone interview yesterday. “They are going be a lot more restrictive, a lot more stringent with their regulations.”
J&J gained 8 cents to $59.69 at 4 p.m. in New York Stock Exchange composite trading. The New Brunswick, New Jersey-based company has fallen 7.1 percent in the past 12 months, compared with a 1.8 percent average gain among 52 stocks in the Standard & Poor’s Health-Care Index.
Children’s Medicines J&J shut down the Fort Washington plant about a year ago after FDA inspectors found signs of contamination that forced the recalls of more than 40 types of children’s liquid pain and allergy medicines including Tylenol and Benadryl. Since then, the company has withdrawn Rolaids, Sudafed and other products because of unusual texture, improper labeling or insufficiencies in the manufacturing process.
The FDA had “numerous meetings and teleconferences” with McNeil and J&J officials since 2009 to address violations found in inspections of the three plants, the Justice Department said in its complaint.
“Although McNeil has initiated a corrective action plan and made some improvements with respect to personnel and operations as a result of these meetings, recent FDA inspections have confirmed that violations persist and additional work is needed to fully address deficiencies and achieve sustained compliance with the law,” the Justice Department said.
“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
McNeil will operate the facilities in Lancaster and Puerto Rico as it addresses the findings of the independent expert. The company said in a statement that it expects the consent decree will govern the operations of the facilities for at least five years after the remediation plan is in place.
The consent decree “is not a complete surprise” and may decrease J&J’s earnings per-share about 5 cents, or $200 million pretax, said Michael Weinstein, an analyst with JPMorgan Securities in New York, in a note to clients.
The consent decree “lays out a specific game plan and timeline” for bringing McNeil’s facilities into compliance, Ira Loss, an analyst with Washington Analysis, said yesterday in a telephone interview.
“Most responsible companies have the discipline and desire to meet the targets,” said Loss, who has followed the FDA for more than three decades. “The uncertainty is over for the McNeil division.”
The FDA will charge McNeil for follow-up inspections at a rate of as much as $104.97 per hour for lab analysis. The consent decree also doesn’t preclude future criminal charges, the agency said. J&J has disclosed in filings that the U.S. Attorney’s Office in Philadelphia issued grand jury subpoenas seeking documents relating to the recalls and FDA inspections of the plants in Fort Washington and Lancaster.
“We are a company that strives to do the right thing, and we succeed far more often than not,” J&J Chief Executive Officer William Weldon said yesterday in a note to employees on the company’s blog. “When we don’t succeed, it’s painful. But, consistent with our credo, we take responsibility for our actions, and we learn from our mistakes.”
Previous Recalls McNeil is among J&J’s units that have drawn scrutiny over product defects. The company’s Cordis unit failed to ensure that heart stents made at a Puerto Rico factory worked properly, the FDA said in a Feb. 16 warning letter released this week. The DePuy Orthopaedics division recalled a hip-replacement system in August, at a cost of $280 million, and faces more than 500 lawsuits by patients who had the implants.
Products recalled last month by J&J and its subsidiaries include Animas insulin cartridges that may leak, possibly cracked syringes of Invega Sustenna for schizophrenia, defective Simponi injectable pens for arthritis and vials of discolored Dermabond skin adhesive.
The consent decree filed yesterday with McNeil, the FDA and the Justice Department must be approved by the U.S. District Court for the Eastern District of Pennsylvania.
Source : Bloomberg
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Drug recalls hit a new record in 2009, with one company accounting for more than 1,000 of them.
Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data. One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.
"We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development."
The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls."
High-profile recalls of Tylenol and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson (JNJ, Fortune 500), have drawn attention to quality concerns in manufacturing.
The mounting problems over recalls have also drawn attention from lawmakers. Two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls.
The spike in recalls, especially of generic and over-the-counter drugs, is being driven by manufacturing lapses, experts say. Some of the biggest culprits: the quality of raw materials, faulty labeling and packaging and contamination.
Increased FDA scrutiny of drug production facilities may also be triggering recalls.
For its part, the FDA maintains that it hasn't identified any alarming patterns in last year's recalls.
An FDA official told the Gold Sheet that 2009 saw no increase in recall "incidents" -- or recalls involving one product problem at a company -- just more recalls per incident.
"Since every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year," FDA spokeswoman Elaine Gansz Bobo told CNNMoney. "At this time, however, we have not identified any trends."
Cause for concernA number of factors are fueling the recall surge.The stampede by drugmakers to be first to bring generic versions to market, after drugs lose patent protection, is one of them.
"The first applicant typically gets the lion's share of the business for the new drug," said Cox.
Generic drugs account for about three quarters of all prescription drug sales, according to industry group PhRMA.
In their hurry, drugmakers sometimes fail to spend enough time time learning how best to make the drug.
For example, Detroit-based Caraco Pharmaceutical Laboratories issued four "tablet-thickness" recalls on March 31, 2009, an additional one on June 8 and yet another recall on April 17 for products that might have been contaminated, said Cox.
"So they get the application. They make and market the drug, but they could still have problems down the road if they haven't really understood the optimum way to make that drug," said Cox.
Caraco could not be reached for comment.
Drugmakers aren't the only ones that have run into problems. Repackagers that relabel drugs into smaller units for resale or distribution to health care facilities, have also had serious lapses.
Advantage Dose, which led last year's recalls by far, is one such company. It issued 1,106 recalls last year following the FDA's inspection of its facility in late 2008. According to the Gold Sheet report, the FDA's inspection listed a wide range of manufacturingproblems.
Cost pressuresAnother reason for the recalls: Cost cutting that goes too close to the bone.
Drugmakers, facing intense competition, are trimming manufacturing investment or outsourcing production, said Prabir Basu, executive director of the National Institute for Pharmaceutical Technology and Education, a nonprofit scientific and research organization.
"It is very expensive to make drugs. It also costs a lot of money to maintain adequate quality controls," Basu said. "You have to invest a lot."
And since generic and over the counterdrugs aren't as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.
"We still have the best at drug manufacturing here in the United States. But if we're seeing signs of trouble, imagine what's happening outside of the U.S. in other countries from where we import drugs," said Basu.
The Gold Sheet report said that 165 recalls last year were of products made, or believed to be made, abroad. That was up 58% from 2008.
"Overall, I am concerned about the quality of drugs," said Basu.
SOURCE : CNNMONEY.COM
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