The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0179-2016·Announced 2015-11-18

B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection found GMP violations that may affect 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml) Injection, 10 mL vials. The recall is due to a lack of assurance of sterility, as an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.

The affected product is a prescription injection distributed in California and New Jersey. The specific lot code is 08032015@4, with an expiration date of 1/30/2016.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/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)

  • 08032015@4
  • exp 1/30/2016

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