Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Broken Tablets
Watson Laboratories is recalling 717 bottles of Hydrocodone Bitartrate and Acetaminophen tablets because the product contains broken tablets.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves broken tablets which is a quality defect rather than a high-risk pathogen or structural defect causing injury.
Plain-English summary
Watson Laboratories, Inc. is recalling 717 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/660 mg, 100 count bottles. The recall was initiated because the product failed tablet specifications and contains broken tablets.
The affected product is identified by Lot # 697316A with an expiration date of March 2015. The product was distributed nationally in Arizona, California, Connecticut, Florida, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, and Wisconsin.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 717
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 #: 697316A
- Expiry: Mar 2015.
Distribution
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