L-Cysteine Hydrochloride Injection — Class II drug recall D-0141-2017
Terminated recall by Sandoz Inc, reported 2016-11-23, distributed nationwide. Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the pro
| Recall number | D-0141-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2016-11-09 |
| Classified | 2016-11-17 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 33,624 vials |
| Reason classes | sterility |
| NDC | 66758-0005-01, 66758-0005-02 |
| Lot numbers | 07/17, 09/17, 10/17, 12/17, 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, 2092315, 2093015, 2100115, 2120115, 2120215 |
Product
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Reason for recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
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-0141-2017. 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.