Recalls / Class II
Class IID-66447-002
Product
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01.
- Brand name
- Irinotecan Hydrochloride
- Generic name
- Irinotecan Hydrochloride
- Active ingredient
- Irinotecan Hydrochloride
- Route
- Intravenous
- NDCs
- 0143-9701, 0143-9702
- FDA application
- ANDA091032
- Affected lot / code info
- Lot #: AC0026, AC0027, Exp 10/14
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.
Recalling firm
- Firm
- West-Ward Pharmaceutical Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 9813 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-23
- FDA classified
- 2013-11-04
- Posted by FDA
- 2013-11-13
- Terminated
- 2016-04-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-66447-002. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.