FDA Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
First Pharma Associates is recalling Hydroxyprogesterone Caproate 250 mg/mL injections due to a lack of assurance of sterility. The recall affects vials distributed in Idaho and Washington.
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 severity rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an injectable drug) corresponds to a score of 4 (Severe), as it is not a Class I recall but involves a significant hazard.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vials, manufactured by First Pharma Associates LLC dba Riverpoint Pharmacy. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is a prescription-only medication. The specific lot number is 05152019@17, with an expiration date of 08/13/2019. The product was distributed only in the states of Idaho and Washington.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that 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 Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
- Category
- Drug — Injectable Medication
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)
- Lot #: 05152019@17
- Exp. 08/13/2019
Distribution
Part of a larger recall action
This product is one of 18 recalled by First Pharma Associates LLC dba Riverpoint Pharmacy 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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