The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0171-2016·Announced 2015-11-18

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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

Distributed in 2 states:

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.

See all 16 products in this recall →

Related recalls

Same manufacturer · Pacific Healthcare, Inc dba B&B Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls