The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0176-2016·Announced 2015-11-18

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

B&B Pharmacy is recalling specific vials of PAPA/PGE1/PHENTO Injection because FDA inspections 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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Pacific Healthcare, Inc dba B&B Pharmacy is recalling specific 5 mL and 10 mL vials of PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection. The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected products are prescription-only injections distributed in California and New Jersey. The specific lots involved are 5 mL vials with lot number 07062015@1 and expiration date 1/2/2016, and 10 mL vials with lot number 07272015@3 and expiration date 1/23/2016.

Consumers and healthcare providers should stop using these specific vials and contact their pharmacist or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability of temporary or medically reversible health consequences.

The recalled product

Product
PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/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 (4)

  • 5 ml --- 07062015@1
  • exp 1/2/2016
  • ---- 10 ml --- 07272015@3
  • exp 1/23/2016

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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