Reported May 26, 2021 · Terminated
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile,…
Teva Pharmaceuticals USA
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: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01
- ALSO LABELED UNDERNOVAPLUS
- Manufactured ByTeva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
- Lot codes and dates
- NDC 0703-5145-01
Lot # 31325332Bexp. date 08/2021Lot # 31325756Bexp
- date 09/2021 AND NDC 0703-5145-91
Lot # 31325685Bexp. date 09/2021
- NDC 0703-5145-01
- Amount recalled
- 192,277 cartons/1 single dose vial per carton
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
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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