FDA Drug recall D-0806-2018
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only by Prescript Pharmaceuticals, citing 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¿….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0806-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-24 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Prescript Pharmaceuticals |
| Distribution | CA |
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
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).
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 # 0130131, EXP 8/31/20 |
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-0806-2018%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.