The Recall Desk
SevereFDA (Drugs)·D-0169-2016·Announced 2015-11-18

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

B&B Pharmacy is recalling PAPA+PGE1+PHENTO Injection vials because an FDA inspection found GMP violations that may affect 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 death if the product is contaminated.

Plain-English summary

Pacific Healthcare, Inc dba B&B Pharmacy is recalling specific lots of PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected product consists of 31 10 mL vials and 16 5 mL vials. These vials were distributed in California and New Jersey. The recall covers specific lots with manufacturing dates ranging from May 2015 to August 2015 and expiration dates ranging from October 2015 to February 2016.

Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on return or disposal. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Manufacturer
Pacific Healthcare, Inc dba B&B Pharmacy
Category
Drug — Injectable
Hazard

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 (20)

  • 5 mL 06022015@11
  • exp 11/29/2015
  • 06082015@5
  • exp 12/5/2015
  • 06112015@7
  • exp 12/8/2015
  • 06112015@9
  • 06162015@7
  • exp 12/13/2015
  • 07092015@6
  • exp 1/5/2016
  • 07092015@7
  • 07162015@4
  • exp 1/12/2016
  • 07202015@1
  • exp 1/16/2016
  • 07202015@2
  • 08032015@6
  • exp 1/30/2016
  • 08142015@12

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

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Same hazard · sterility

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