Recalls / Class II
Class IID-0140-2017
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.
- Affected lot / code info
- Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17
Why it was recalled
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 18,751 vials
- Distribution pattern
- Nationwide throughout the USA
Timeline
- Recall initiated
- 2016-11-09
- FDA classified
- 2016-11-17
- Posted by FDA
- 2016-11-23
- Terminated
- 2017-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0140-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.