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
Reported: April 10, 2019 Initiated: March 15, 2019 #D-1070-2019
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
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
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 701 cartons (25 vials per carton)
- Distribution
- Nationwide USA and Guam
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 701 cartons (25 vials per carton).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2019. Severity: Low. Recall number: D-1070-2019.
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