FDAClass IINovember 18, 2015

Nandrolone 200 mg/ml Injection recall: Sterility Concern

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

Why was Nandrolone 200 mg/ml Injection recalled?

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Recalling firm
Pacific Healthcare, Inc dba B&B Pharmacy
Quantity
2-10ml vials, 1-20ml vial
Distribution
CA and NJ
Recall date
November 18, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls