Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets — Class II drug recall D-0806-2018
Terminated recall by Prescript Pharmaceuticals, Inc., reported 2018-05-23, distributed in CA. Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) whic
| Recall number | D-0806-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prescript Pharmaceuticals, Inc., Pleasanton, CA, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2019-01-23 |
| Distributed | CA |
| Reason classes | labeling |
| NDC | 13107-0058, 13107-0058-01, 13107-0058-05, 13107-0058-30, 13107-0058-99, 13107-0059, 13107-0059-01, 13107-0059-05, 13107-0059-30, 13107-0059-99, 13107-0060, 13107-0060-01, 13107-0060-05, 13107-0060-30, 13107-0060-99 |
| Lot numbers | 0130131 |
| Expiration dates | 2020-08-31 |
Product
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033
Reason for recall
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
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-0806-2018. 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.