a subsidiary of Endo Health Solutions, issued a voluntary, nationwide retail
level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets,
USP 10 mg/500 mg. Bottles from the affected lot 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 3
alcoholic beverages a day.
bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief
of moderate to moderately severe pain. The affected lot, C1440512A, was
distributed between May 14 and Aug. 3, 2012 to wholesale distributors and
retail pharmacies nationwide. The lot number can be found on the side of the
manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are
approximately 16.51 mm in length, pink, capsule-shaped tablets, with
"3600" debossed on one side of the tablet and "V" on the
Consumers who have lot C1440512A should contact Qualitest at 1-800-444-4011.
Consumers who are unsure if they have the affected lot number should consult
their pharmacy or health care professional. Pharmacists and wholesalers are
asked to check their inventories for lot C1440512A, segregate any material from
the lot, and to contact MedTurn at 1-800-967-5952 for
instructions on product return.
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
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
form 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
Read the MedWatch safety alert, including a link to the Press Release, here.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 9/12/2012)