FDAFDA · Food and drugs·Recall number D-0165-2021
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
Published December 23, 2020 · Recall initiated: December 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Vials may not be sealed correctly affecting sterility.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- CIPLA
- Distributor
- USA Nationwide
- Lot
- Lot #: 7S10182A, Ex 9/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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