The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-556-2013·Announced 2013-06-12

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.

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. 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

Distributed in 4 states:

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.

See all 25 products in this recall →

Related recalls

Same manufacturer · THE COMPOUNDING SHOP, INC.

See all →

Same hazard · sterility

See all →

Similar recalls