Acetaminophen and Codeine Phosphate 300/30 mg tablet — Class II drug recall D-1246-2020
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2020-04-22, distributed in AZ, CA. cGMP Deviations
| Recall number | D-1246-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2020-04-15 |
| Classified | 2020-04-16 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2024-02-14 |
| Distributed | AZ, CA |
| Quantity | 9,000 tablets |
| Reason classes | cgmp |
| NDC | 52959-0003-10, 52959-0003-12, 52959-0003-14, 52959-0003-15, 52959-0003-16, 52959-0003-20, 52959-0003-30, 52959-0003-60 |
| Lot numbers | 05/21, ATP12ZT |
Product
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
Reason for recall
cGMP Deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1246-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.