PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Reported: November 18, 2015 Initiated: October 7, 2015 #D-0176-2016
Product Description
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Reason for Recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Details
- Recalling Firm
- Pacific Healthcare, Inc dba B&B Pharmacy
- Units Affected
- 1- 5ml vial, 1- 10 ml vial
- Distribution
- CA and NJ
- Location
- Bellflower, CA
Frequently Asked Questions
What product was recalled? ▼
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA. Recalled by Pacific Healthcare, Inc dba B&B Pharmacy. Units affected: 1- 5ml vial, 1- 10 ml vial.
Why was this product recalled? ▼
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 18, 2015. Severity: Moderate. Recall number: D-0176-2016.
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