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Class II · ModerateRecall completed

L-Cysteine Hydrochloride Injection

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 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
Where it was soldNationwide throughout the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forSandoz, Inc., Princeton, NJ
NDC66758-005-01
Show the full FDA record
Full product labelL-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 firmSandoz Inc
DistributionNationwide throughout the USA
Quantity33,624 vials
Recall initiated2016-11-09
Report date2016-11-23
Recall completed2017-10-17
Recall numberD-0141-2017
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.