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Recall Observatory FDA recall evidence

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

November 09, 2016

Class II

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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility