Pharmaceutical maker Mylan Inc. is conducting a voluntary nationwide recall of three lots of the pain killers hydrocodone bitartrate and acetaminophen hydrocodone bitartrate tablets, the Pittsburgh company said in a press release.
The three lots were manufactured by Qualitest Pharmaceuticals, and Mylan Institutional repackaged and distributed the product in unit dose (CD100) under the UDL Laboratories, Inc. (n/k/a Mylan Institutional Inc.) label.
Qualitest initiated the recall on Dec. 6 due to the possibility that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen.
http://www.fda.gov/Safety/Recalls/ucm331218.htm
As indicated in Qualitest’s announcement, unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.
In its press release earlier this month Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary recall of 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.
“It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen,” Qualitest said. “Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.”
Qualitest warned that bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.
“Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day,” the press release said. “The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.”
The affected lots were distributed between Feb. 20 and Nov. 19 to wholesale distributors and retail pharmacies nationwide.
It’s crucial that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than six tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.
“Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants,” the press release said.
No injuries have been reported to date, according to Qualitest.
Consumers who have the affected lots should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional.
Pharmacists and wholesalers need to check their inventories for the affected lots, segregate any material from the lots, and contact MedTurn Pharmacies.
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