Reported Nov 23, 2016 · Terminated
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5…
Sandoz Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
- 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 forSandoz, Inc., Princeton, NJ
- Lot codes and dates
Lot #: 20709152071015207141520715152071615207171520721152072215Exp 07/1720923152093015Exp 09/172100115Exp 10/1721201152120215Exp 12/17
- Amount recalled
- 33,624 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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