Drug recall D-0806-2018
Product
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033
Reason for recall
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).
Lots and codes
Lot # 0130131, EXP 8/31/20
Recall details
- Recalling firm
- Prescript Pharmaceuticals, Inc., Pleasanton, CA
- Quantity
- 1 20-count containers
- Distribution
- California.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 24, 2018
- Terminated
- January 23, 2019
Related products
- Acetaminophen and Codeine Phosphate – drug information
- NDC 13107-060 Acetaminophen and Codeine Phosphate · Acetaminophen 300 mg/1; Codeine Phosphate 60 mg/1 · Aurolife Pharma, LLC
- NDC 13107-058 Acetaminophen and Codeine Phosphate · Acetaminophen 300 mg/1; Codeine Phosphate 15 mg/1 · Aurolife Pharma, LLC
- NDC 13107-059 Acetaminophen and Codeine Phosphate · Acetaminophen 300 mg/1; Codeine Phosphate 30 mg/1 · Aurolife Pharma, LLC