Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns
Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Cypionate 250 mg/mL Injection due to FDA inspection findings of GMP violations that may impact 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Cypionate 250 mg/mL Injection, 10 mL vials. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product is a prescription medication distributed in California and New Jersey. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring in October and November 2015.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
- Manufacturer
- Pacific Healthcare, Inc dba B&B Pharmacy
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 3
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 (6)
- 07282015@7
- exp 10/26/2015
- 07292015@6
- 10/27/2015
- 08252015@4
- 11/23/2015
Distribution
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.
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