Recalls / Class II
Class IID-0809-2018
Product
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834
- Affected lot / code info
- Lot # 0130130 EXP 12/31/20
Why it was recalled
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Recalling firm
- Firm
- Prescript Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 39 California Ave Ste 104, Pleasanton, California 94566-6279
Distribution
- Quantity
- 199 tablets in 20-count containers
- Distribution pattern
- California.
Timeline
- Recall initiated
- 2018-04-24
- FDA classified
- 2018-05-14
- Posted by FDA
- 2018-05-23
- Terminated
- 2019-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0809-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.