The Recall Desk
SevereFDA (Drugs)·D-0166-2016·Announced 2015-11-18

Nandrolone Injection Recalled Due to Sterility Assurance Concerns

Pacific Healthcare is recalling Nandrolone 200 mg/ml Injection vials because an FDA inspection found GMP violations that may impact 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.

Plain-English summary

Pacific Healthcare, Inc dba B&B Pharmacy is recalling Nandrolone 200 mg/ml Injection, 10 mL and 20 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 codes and expiration dates are listed in the recall documentation. The source text does not report any illnesses or injuries associated with these products.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

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)

  • 10 ml-- 05252015@2
  • exp 10/23/2015
  • 06252015@2
  • exp 10/23/2015 20 mL-- 06252015@2

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 →