Why it was recalled
Lack of Assurance of Sterility
Product description
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
Lot numbers, UPCs & expiration codes
Lots: 68-104-EV; Exp 07/31/18, 73-155-EV; Exp. 12/31/18, 73-156-EV; Exp.12/31/18
Where it was sold
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-0940-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 72,575 4 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-0940-2017, exactly as published.
Show all FDA fields
- City
- Pine Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77545
- Address
- 10 Bloomfield Ave Bldg B Ste 2
- Code information
- Lots: 68-104-EV; Exp 07/31/18, 73-155-EV; Exp. 12/31/18, 73-156-EV; Exp.12/31/18
- Postal code
- 07058-9743
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0940-2017
- Classification
- Class II
- Recalling firm
- Alvogen, Inc
- Product quantity
- 72,575 4 mL vials
- Termination date
- Oct 30, 2019
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 16, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jul 3, 2017