Drug recall D-1231-2020
Product
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots and codes
Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 57337 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