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.
Reported: November 23, 2016 Initiated: November 9, 2016 #D-0141-2017
Product Description
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 for Recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 33,624 vials
- Distribution
- Nationwide throughout the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz Inc. Units affected: 33,624 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 23, 2016. Severity: Moderate. Recall number: D-0141-2017.
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