FDA Drug recall D-0815-2021
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only,…
- FDA Drug
- Class II
- completed
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only,… by Morton Grove Pharmaceuticals, citing CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0815-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-09-03 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Morton Grove Pharmaceuticals |
| Distribution | US |
Product
Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16
Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Identifiers
| code_info | Lot #: UV1198 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0815-2021%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.