The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1002-2013·Announced 2013-09-18

FDA Recalls Testosterone Injectable Due to Sterility Assurance Concerns

Beacon Hill Medical Pharmacy is recalling Testosterone Hypoallergenic and Testosterone Aqueous injectables due to FDA inspectional findings regarding sterility assurance.

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 source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4; however, FDA Class II with significant quality control failures impacting sterility assurance in injectable drugs warrants a score of 4 (Severe) due to the high risk of serious injury from non-sterile administration.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling Testosterone Hypoallergenic 200 mg/mL Injectable and Testosterone Aqueous 100 mg/mL Injectable. The products are compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, MI, and are distributed nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II.

Patients who have received these products should contact their healthcare provider for guidance. The specific lot codes associated with this recall are 03112013@9, 05242013@17, 05312013@7, and 06052013@21.

The recalled product

Product
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Manufacturer
Beacon Hill Medical Pharmacy, P.C.
Category
Drug — Injectable
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)

  • 03112013@9
  • 05242013@17
  • 05312013@7
  • 06052013@21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →

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