Watson Recalls Oxycodone and Acetaminophen Capsules Due to Low Potency
Watson Laboratories is recalling two lots of Oxycodone and Acetaminophen Capsules because the oxycodone content was found to be below specification at expiry.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than an acute safety threat like contamination or mislabeling of a dangerous allergen.
Plain-English summary
Watson Laboratories, Inc. is recalling two lots of Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg. The affected products are packaged in 100-count bottles (NDC 0591-0737-01) and 500-count bottles (NDC 0591-0737-05). The total quantity involved is 1,260 bottles, which were distributed nationwide.
The recall was initiated because testing at the 24-month expiry date revealed that the oxycodone portion of the product had a low out-of-specification (OOS) assay result. This means the medication may not contain the full prescribed amount of the active ingredient.
The specific lots affected are Lot # 444971A (Expiration 8/13) and Lot # 444973A (Expiration 8/13). Patients and healthcare providers should check their medication bottles for these lot numbers and expiration dates. If the medication matches the recalled lots, it should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,260
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 # a) 444971A
- Exp 8/13
- b) 444973A
Distribution
Distributed nationwide across the United States.
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