Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Product description
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
Lot numbers, UPCs & expiration codes
Lot: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (exp 10/2019)
Where it was sold
Nationwide USA and Guam
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-1070-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 15, 2019
- FDA report date
- Apr 10, 2019
- Quantity
- 701 cartons (25 vials per carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1070-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82386
- Address
- 235 E 42nd St
- Code information
- Lot: T97472 (exp 07/2019), T97473 (exp 04/2019), W28573 (exp 09/2019), W31814 (exp 10/2019)
- Postal code
- 10017-5703
- Report date
- Apr 10, 2019
- Product type
- Drugs
- Recall number
- D-1070-2019
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 701 cartons (25 vials per carton)
- Termination date
- Aug 11, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
- Distribution pattern
- Nationwide USA and Guam
- Recall initiation date
- Mar 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2019