Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Superpotent Risk
Watson Laboratories is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen tablets because they may be oversized and superpotent.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.
Plain-English summary
Watson Laboratories, Inc. is recalling 4,874 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count. The affected product is prescription-only and was distributed nationwide. The specific lots involved are 519406A and 521759A, both with an expiration date of 04/14.
The recall was initiated because there is a potential for the tablets to be oversized and superpotent. This condition could result in patients receiving a higher dose of the medication than intended.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Affected units
- 4,874
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 (3)
- Lot #: 519406A
- 521759A
- Exp 04/14
Distribution
Distributed nationwide across the United States.
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Similar recalls
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