Qualitest, a supplier of generic pharmaceuticals, has made a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets.  Hydrocodone Bitartrate and Acetaminophen Tablets are used to treat pain.  According to the FDA, the recalled tablets may exceed the weight and potency requirements for the ingredients Hydrocodone Bitartrate and Acetaminophen.  Increased acetaminophen may cause liver toxicity for individuals taking the tablets. 

Recalled Product Information:

  • Product Name: Hydrocodone Bitartrate and Acetaminophen Tablets
  • USP: 10 mg/500 mg
  • Lot Number: numbers beginning with the letter “C”
  • Distribution Dates: Feb. 20, 2012 and Nov. 19, 2012
  • Color of Tablet: pink
  • Length of Tablet: approximately 16.51 mm
  • Marks on Tablet: “3600” debossed on one side and “V” on the other

To view the label of the recalled Hydrocodone Bitartrate and Acetaminophen Tablets, click here.

Reason for Recall according to the FDA:

  • Tablets may exceed the weight and potency requirements for the ingredients Hydrocodone Bitartrate and Acetaminophen
  • Tablets with a higher than intended dosage of acetaminophen may cause liver toxicity in patients
  • Taking more than the intended dose of hydrocodone could result in an increase in the severity of sedation or respiratory depression

Refund:

Pharmacists and wholesalers who have the affected lots in their inventories should contact MedTurn at 1-800-967-5952 for instructions on product return.

Additional Information

Customers with additional questions regarding the recall may contact Qualitest at 1-800-444-4011.  For quick answers regarding the recall, you may also go directly to the FDA recall page.

What to Do if a Recalled Product Has Affected You

If you or a loved one has become injured as a result of a recalled product, you may be entitled to compensation.  It would be beneficial to speak to an attorney specializing in products liability today.

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