PGE 20mcg/ml Injection Recalled Due to Sterility Assurance Concerns
Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 20mcg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Pacific Healthcare, Inc dba B&B Pharmacy is recalling 3 vials of PGE 20mcg/ml Injection, 10 mL vial, Rx. The product was distributed in California and New Jersey. Specific lot codes and expiration dates are listed in the recall documentation.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. There is a lack of assurance of sterility for the affected units.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on return or disposal.
The recalled product
- Product
- PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
- Manufacturer
- Pacific Healthcare, Inc dba B&B Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 05072015@7
- exp 11/3/2015
- 05182015@3
- 11/14/2015
- 07152015@
- 1/11/2016
Distribution
Part of a larger recall action
This product is one of 16 recalled by Pacific Healthcare, Inc dba B&B Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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