Metronidazole Injection — Class II drug recall D-0616-2017
Terminated recall by Claris Lifesciences Inc, reported 2017-04-05, distributed nationwide. Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a
| Recall number | D-0616-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Claris Lifesciences Inc, North Brunswick, NJ, United States |
| Recall initiated | 2017-03-10 |
| Classified | 2017-03-24 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2020-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 72,072 units |
| Reason classes | sterility, packaging |
| NDC | 36000-0001-24 |
| Lot numbers | A060205, A060209 |
| Expiration dates | 2018-01-20 |
Product
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
Reason for recall
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
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-0616-2017. 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.