Recalls / Class II
Class IID-0126-2021
Product
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
- Brand name
- Docetaxel
- Generic name
- Docetaxel
- Active ingredient
- Docetaxel
- Route
- Intravenous
- NDC
- 72485-216
- FDA application
- ANDA210327
- Affected lot / code info
- Lot #: 7S10185A, Exp. 10/31/2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Shilpa Medicare Limited
- Manufacturer
- Armas Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- S-20 To S-26, Pharm. Formulation Sez, Tsiic, Green Industrial Park, Polepally, Jadcherla, N/A N/A, India
Distribution
- Quantity
- 2008 vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-12-08
- FDA classified
- 2020-12-09
- Posted by FDA
- 2020-12-16
- Terminated
- 2022-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0126-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.