Qualitest Recalls Hydrocodone and Acetaminophen Tablets Due to Oversized Pills
Vintage Pharmaceuticals is recalling 14,445 bottles of hydrocodone and acetaminophen tablets because confirmed complaints found oversized pills with superpotent drug levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric. The hazard involves superpotent drug levels, which poses a significant risk of adverse health consequences.
Plain-English summary
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals is recalling 14,445 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg, 100-count. The affected product is identified by Lot number C1440512A and an expiration date of 12/13. The recall is being conducted under FDA recall number D-057-2013.
The recall was initiated due to confirmed customer complaints that the tablets were oversized. These oversized tablets resulted in superpotent assays of both the hydrocodone and acetaminophen components, meaning the pills contained higher amounts of the active ingredients than intended.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.
The recalled product
- Product
- HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
- Category
- Drug — Prescription Medication
- Affected units
- 14,445
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 number: C1440512A
- Exp 12/13
Distribution
Distributed nationwide across the United States.
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