PGE 25mcg/ml Injection Recalled Due to Sterility Assurance Concerns
Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 25mcg/ml Injection vials because an FDA inspection identified 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 rubric specifies that FDA Class II recalls involving potential sterility issues or significant injury risks are categorized as Severe.
Plain-English summary
Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 25mcg/ml, Injection, 10 mL vials. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a prescription injection distributed in California and New Jersey. The specific code information for the recalled units is 08242015@5, with an expiration date of 2/20/2016.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacy or the recalling firm for instructions on how to return the product.
The recalled product
- Product
- PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
- Manufacturer
- Pacific Healthcare, Inc dba B&B Pharmacy
- Category
- Drug — Injection
- Hazard
- Affected units
- 1
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 (2)
- 08242015@5
- exp 2/20/2016
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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