Drug product
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
D-0140-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 75654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,751 vials
- Official record key
drug-enforcement:D-0140-2017
Official wording
Reason: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Code information: Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17
Distribution pattern: Nationwide throughout the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility