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
Reported: July 12, 2017 Initiated: June 16, 2017 #D-0940-2017
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 72,575 4 mL vials
- Distribution
- Nationwide
- Location
- Pine Brook, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Alvogen, Inc. Units affected: 72,575 4 mL vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 12, 2017. Severity: Moderate. Recall number: D-0940-2017.
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