The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0168-2016·Announced 2015-11-18

Testosterone Propionate Injection Recalled for Sterility Assurance Concerns

Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Propionate 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4), as they are not Class I but involve significant quality violations.

Plain-English summary

Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Propionate 200 mg/ml Injection, 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 codes include 07282015@8 (expiration 10/26/2015) and 07302015@4 (expiration 10/28/2015). The recall involves 2 vials per unit as described in the product information.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone prop. 200 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
2

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)

  • 07282015@8
  • exp 10/26/2015
  • 07302015@4
  • exp 10/28/2015

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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