The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0174-2016·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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 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 products are prescription (Rx) vials distributed in California and New Jersey. Specific lot information includes 5 mL vials with a manufacture date of 07/06/2015 and expiration date of 01/02/2016, and 10 mL vials with manufacture dates of 06/04/2015, 06/05/2015, and 07/13/2015, with corresponding expiration dates of 12/01/2015, 12/02/2015, and 01/09/2016.

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

The recalled product

Product
PAPA/PGE1/PHENTO (30mg/10mg/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 Medication
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 (7)

  • 5 ml --- 07062015@2
  • exp 1/2/2016 10 ml --- 06042015@4
  • exp 12/1/2015
  • 06052015@15
  • exp 12/2/2015
  • 07132015@3
  • exp 1/9/2016

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 →

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