AMIKACIN SULFATE INJECTION — Class I drug recall D-1398-2019
Terminated recall by Heritage Pharmaceuticals, Inc., reported 2019-06-19, distributed nationwide. Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and
| Recall number | D-1398-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2019-05-21 |
| Classified | 2019-06-19 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2022-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 14,960 |
| Reason classes | microbial contamination, sterility |
| NDC | 23155-0290, 23155-0290-31, 23155-0290-32, 23155-0290-41, 23155-0290-42 |
| Lot numbers | VEAC025 |
| Expiration dates | 2019-10 |
Product
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
Reason for recall
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) .
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-1398-2019. 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.