L-Cysteine Hydrochloride Injection recall: Sterility Concern
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.
Why was L-Cysteine Hydrochloride Injection recalled?
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17; 2100115, Exp 10/17; 2120115, 2120215, Exp 12/17
- Product
- 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.
- Recalling firm
- Sandoz Inc
- Quantity
- 33,624 vials
- Distribution
- Nationwide throughout the USA
- Recall date
- November 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)