FDA Drug recall D-1397-2019
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India
- FDA Drug
- Class I
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class I recall of PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India by Heritage Pharmaceuticals, citing non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1397-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-05-21 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
Product
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
Reason
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Identifiers
| ndc | 23155-294-31 |
|---|---|
| ndc | 23155-294-42 |
| ndc | 23155-294-41 |
| code_info | Lot: VPCA172, EXP April 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Heritage Pharmaceuticals
- CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Br…
FDA Drug · Class II · 2026-08-19 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman,…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
All Heritage Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1397-2019%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.