Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Defective Seals
Watson Laboratories is recalling 875 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets because defective bottles may have improperly seated tamper-evident seals.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging defect (tamper-evident seal) rather than a direct health hazard.
Plain-English summary
Watson Laboratories, Inc. is recalling 875 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg, 500 count. The affected product is identified by NDC 0591-2611-05 and includes Lot 706224A and 706225A with an expiration date of 04/15. The product was distributed nationwide.
The recall is being conducted because the bottles may have defective tamper-evident seals that are not properly seated. This defect makes it difficult to determine if the product had been opened or tampered with. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this product should check the lot numbers and expiration dates on their bottles. If the product matches the recalled description, consumers should contact Watson Laboratories for further instructions or return the product to the pharmacy where it was purchased.
The recalled product
- Product
- Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Affected units
- 875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 706224A and 706225A
- Exp. 04/15.
Distribution
Distributed nationwide across the United States.
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