Class II
Terminated
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.
- Company
- Sandoz Inc
- Recall Initiated
- November 9, 2016
- Posted
- November 23, 2016
- Recall Number
- D-0140-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,751 vials
- Firm Location
- Princeton, NJ, United States
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.
Distribution
Nationwide throughout the USA
Lot / Code Info
Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17
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