Safety Alert: Voluntary Recall
Tuesday, July 5th, 2011
Pain Medications Voluntarily Recalled for Mislabeling
Endo Pharmaceuticals, Inc., and Qualitest, a generic drug manufacturing subsidiary, issued voluntary recalls of certain lots of oxycodone with acetaminophen (Endocet), hydrocodone with acetaminophen (generic Vicodin) and butalbital, acetaminophen and caffeine (generic Fioricet) because some bottles may contain different strength tablets, resulting in individuals taking more than or less than the intended doses of active ingredients.
According to the Food and Drug Administration’s (FDA) safety alert:
Qualitest Pharmaceuticals issued a voluntary nationwide recall at the retail level for
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generic butalbital, acetaminophen and caffeine tablets USP, 50mg/325mg/40mg, and generic hydrocodone bitartrate and acetaminophen tablets, USP 7.5mg/500mg. One bottle of butalbital, acetaminophen and caffeine tablets was found incorrectly labeled with a hydrocodone bitartrate and acetaminophen tablets, USP 7.5mg/500mg, 1000 count label, printed with lot number C0590909B.
An accidental dosage of generic butalbital/acetaminophen/caffeine (Fioricet) could cause sedation, lightheadedness, dizziness, nausea, hypersensitivity, tremors, irritability and difficulty sleeping. Those who normally take generic hydrocodone bitartrate/acetaminophen (Vicodin) could experience withdrawal symptoms and worsening of pain due to missed doses of that opioid.
Endo Pharmaceuticals issued a voluntary nationwide consumer level recall for
- Endocet (oxycodone/acetaminophen) USP tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, lot numbers 402415NV and 402426NV. One bottle from each lot was found to contain a higher acetaminophen dose. This can be recognized by their larger size, and different shape and markings.
Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in people taking other acetaminophen-containing medications, people with liver dysfunction, or people who consume more than three alcoholic beverages a day.
If you are taking a generic version of Fioricet (butalbital products) or Vicodin (hydrocodone products) or the brand Endocet, please check your lot numbers immediately.
Lot numbers can be found on the side of the bottle. The medications look different from each other. The two Qualitest products are:
- The white, round-shaped tablet with “2355” debossed on one side is the butalbital/acetaminophen/caffeine tablets (generic form of Fioricet).
- The white with green specks, capsule-shaped tablet and debossed with “3594” on one side is the hydrocodone bitartrate/acetaminophen tablets (generic form of Vicodin).
The Endo brand formulations of oxycodone/acetaminophen (Endocet) are:
- Capsule-shaped 10 mg/325 mg tablets with an “E712” marking on one side and a “10/325” marking on the other.
- Oval-shaped 10 mg/650mg tablet with an “E797” marking on one side and “10” on the other.
Individuals who have these lots in their possession should:
- Stop using the product and contact the manufacturer for disposal and reimbursement information.
- Qualitest at (800) 444-4011
- Endo’s agent Stericycle at (866) 723-2681
- Notify the pharmacy where this medication was filled and report that you are in possession of an affected lot.
- Notify the health care provider who writes your pain medicine prescriptions and ask for guidance.
- Notify you insurance provider should a new prescription be written, so that it will be covered.
- Contact the FDA and report if you have had any adverse reactions described above or trouble receiving replacement medication by:
- Online using FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm;
- Regular mail by using the postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form;
- Fax: (800) FDA-0178.
Consumers with questions may contact the manufacturers for more information.