Qualitest issued a nationwide recall on Sept. 10 of one lot of pain pills to treat moderate to severe pain, according to the U.S. Food and Drug Administration (FDA). One lot of the pills, Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/500 mg, is being recalled because it may contain too much acetaminophen.
The hydrocodone bitartrate and acetaminophen tablets being recalled are Lot C1440512A, distributed between May 14 and Aug. 3, 2012. The medication is prescribed to treat moderate to moderately severe pain.
Some patients who take more than the intended dose of acetaminophen could suffer from liver toxicity if they are taking other medicine containing acetaminophen or if they drink more than three alcoholic beverages daily.
The label on the bottle says that an overdose of acetaminophen has the potential to cause severe liver damage which might require a liver transplant or could cause death. An overdose of hydrocodone could increase the severity of side effects. These include sedation or depression of the respiratory system. This would be a particular problem in:
- The elderly
- Patients who have severe liver or kidney damage
- Those taking certain medications that would interact with the hydrocodone-acetaminophen tablets; such drugs would include other sedating medications and some antidepressants
The lot number is printed on the side of the medication bottle. The tablets are about 16.51 mm long, pink, and in the shape of a capsule. “3600″ is imprinted on one side of the tablet and “V” is imprinted on the other.
No adverse effects have yet been reported.
Patients who have the affected lot should call Qualitest at 1-800-444-4011. Those who are unsure of the identity of their medication should ask their pharmacist or physician.
Qualitest, which produces generic drugs, ranks among the top ten manufacturers of generic medications judged by the total number of prescriptions filled. The company was established in 1983.
Source: FDA
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