A-S Medication Solutions Recalls Acetaminophen and Codeine Tablets Due to Labeling Error
A-S Medication Solutions LLC is recalling 2,730 bottles of Acetaminophen & Codeine Phosphate Tablets because the count on the label was incorrect.
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 as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the product count.
Plain-English summary
A-S Medication Solutions LLC is recalling 2,730 bottles of Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottles. The product is prescription-only and was manufactured by Aurolife Pharma LLC in Dayton, NJ, and packaged exclusively by A-S Medication Solutions LLC in Libertyville, IL. The specific lot number is 6050129, with an expiration date of 05/31/17.
The recall was initiated due to a labeling error where the count on the label was incorrect. This issue is classified as 'Not elsewhere classified' by the FDA. The affected product was distributed in Virginia.
Consumers who have this product should contact their pharmacist or healthcare provider for guidance. 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.
The recalled product
- Product
- Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
- Manufacturer
- A-S Medication Solutions LLC.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,730
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 # 6050129
- Exp 05/31/17
Distribution
Distributed in 1 state:
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