The Recall Desk
SevereFDA (Drugs)·D-1098-2015·Announced 2015-06-03

Advanced Physician Solutions Recalls Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

Advanced Physician Solutions is recalling Hydroxyprogesterone Caproate injectable vials because the company cannot ensure the product is sterile.

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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Advanced Physician Solutions, Inc. is recalling Hydroxyprogesterone Caproate (Olive Oil) 30ml, 10ml vial 250mg/ml injectable products. The recall was initiated because the company lacks assurance of the sterility of the product.

The recalled product is a 250mg/ml injectable solution in 10ml vials, with a total quantity of 28 vials involved. The distribution pattern is nationwide, and the recall applies to all lots. The product was manufactured by Advanced Compounding Pharmacy located in North Hollywood, California.

Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. No specific dates or lot numbers are provided in the source text.

The recalled product

Product
HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Affected units
28

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 nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Advanced Physician Solutions, 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 18 products in this recall →