Beacon Hill Medical Pharmacy Recalls Hydroxyprogesterone Caproate Injection
Beacon Hill Medical Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to sterility assurance concerns identified during an FDA inspection.
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 and involves a sterile injectable medication where sterility assurance was compromised, posing a risk of serious infection or injury, which aligns with the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection solution. The product is compounded for intravenous and subcutaneous use only and is available in all presentations. The recall is being conducted because FDA inspectional findings raised concerns regarding quality control procedures that impacted the assurance of sterility.
The recall covers the product distributed nationwide in the United States. The source text does not specify the exact number of units affected or the specific dates of distribution, though code information indicates dates in May 2013. No illnesses or injuries are reported in the source text.
Healthcare providers and patients should discontinue use of the recalled 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
- HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, 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 — Compounded Injectable
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)
- 05032013@4
- 05222013@13
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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