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.
Reported: December 16, 2020 Initiated: December 8, 2020 #D-0126-2021
Product Description
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.
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Shilpa Medicare Limited
- Units Affected
- 2008 vials
- Distribution
- Nationwide in the U.S.
- Location
- Polepally, Jadcherla, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shilpa Medicare Limited. Units affected: 2008 vials.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 16, 2020. Severity: Moderate. Recall number: D-0126-2021.
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