FDA Drug recall D-0141-2017
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 ca…
- FDA Drug
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of 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 ca… by Sandoz, citing lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0141-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-09 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Identifiers
| code_info | Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17;…Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17; 2100115, Exp 10/17; 2120115, 2120215, Exp 12/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0141-2017%22
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