D-1231-2020 Class II Terminated
FDA drug recall D-1231-2020 was initiated by Aurobindo Pharma USA Inc. on March 18, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed The recall status is terminated (terminated March 25, 2024). Affected quantity: 57337 units.
Recall Details
- Product Type
- Drugs
- Report Date
- April 22, 2020
- Initiation Date
- March 18, 2020
- Termination Date
- March 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57337 units
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021