Drug recall D-1229-2020
Product
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots and codes
Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 14194 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 18, 2020
- Terminated
- March 25, 2024
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