Beacon Hill Medical Pharmacy Recalls Testosterone Propionate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Testosterone Propionate 100 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.
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. Per the rubric, an FDA Class II recall involving a sterile injectable product with sterility assurance concerns falls under the 'Severe' category, as it represents a significant risk of harm (infection) even if specific hospitalization reports are not detailed in the provided text snippet.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling Testosterone Propionate 100 mg/mL oil injection solution, compounded for intravenous and subcutaneous use. The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures impacting the assurance of sterility.
The affected product is a prescription-only sterile oil injection solution. The recall covers all configurations of the product distributed nationwide in the United States. Specific lot codes identified in the recall notice include 04172013@15 and 06042013@17.
Patients who have received this medication should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with the use of this product.
The recalled product
- Product
- TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, 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.
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 (2)
- 04172013@15
- 06042013@17
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.
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