FDA Drug recall D-1231-2020
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Day…
- FDA Drug
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Day… by Aurobindo Pharma Usa, citing CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1231-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-18 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Identifiers
| ndc | 13107-058-30 |
|---|---|
| ndc | 13107-058-01 |
| ndc | 13107-058-05 |
| ndc | 13107-058-99 |
| ndc | 13107-059-30 |
| ndc | 13107-059-01 |
| ndc | 13107-059-05 |
| ndc | 13107-059-99 |
| ndc | 13107-060-30 |
| ndc | 13107-060-01 |
| ndc | 13107-060-05 |
| ndc | 13107-060-99 |
| code_info | Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1231-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.