FDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns
The Compounding Shop is recalling Hydroxyprogesterone 250 mg/mL injectable vials because FDA inspection findings raised concerns about quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for significant harm (such as sterility issues in injectables) are categorized as Severe (Score 4), particularly when structural or process defects are identified by the agency.
Plain-English summary
The Compounding Shop, Inc. is recalling Hydroxyprogesterone 250 mg/mL Injectable vials in 4 mL, 6 mL, 8 mL, and 10 mL sizes. The recall was initiated after FDA inspection findings resulted in concerns regarding the quality control processes used to ensure the sterility of the product.
The affected product consists of 12 vials of 4 mL, 1 vial of 6 mL, 1 vial of 8 mL, and 3 vials of 10 mL. All lots are included in this recall. The product was distributed in Florida, California, Minnesota, and Maine.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- 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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. 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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