Why it was recalled
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 7S10182A, Ex 9/2021
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0165-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 14, 2020
- FDA report date
- Dec 23, 2020
- Quantity
- 2151 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CIPLA
Original FDA data
Every field from FDA enforcement report D-0165-2021, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86969
- Address
- 10 Independence Blvd
- Code information
- Lot #: 7S10182A, Ex 9/2021
- Postal code
- 07059-2730
- Report date
- Dec 23, 2020
- Product type
- Drugs
- Recall number
- D-0165-2021
- Classification
- Class II
- Recalling firm
- CIPLA
- Product quantity
- 2151 vials
- Termination date
- Aug 16, 2022
- Reason for recall
- cGMP deviations: Vials may not be sealed correctly affecting sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Dec 14, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 16, 2020