Reported Nov 13, 2013 · Terminated
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured…
West-Ward Pharmaceutical Corp.
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: West-Ward Pharmaceutical Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209
Is this the product you have?
- Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only
- Manufactured byThymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany
- Distributed byWest-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01
- Lot codes and dates
Lot #: AC0026AC0027Exp 10/14
- Amount recalled
- 9813 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
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
This product could cause temporary or reversible health problems — stop using it.
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