Agency classClass IIOur severity:Severe FDA (Drugs)·D-1474-2019·Announced 2019-07-17

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.

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 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
Manufacturer: First Pharma Associates LLC dba Riverpoint Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility
infection

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

Distributed in 2 states:

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.

See all 18 products in this recall →

Same manufacturer · First Pharma Associates LLC dba Riverpoint Pharmacy

See all →

Severe
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FDA (Drugs) · 2019-07-17
Severe
Methylcobalamin Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-07-17
High
Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-07-17
Severe
Riverpoint Pharmacy Recalls Chorionic Gonadotropin Injection Due to Sterility Concerns
FDA (Drugs) · 2019-07-17
Severe
Riverpoint Pharmacy Recalls Testosterone Cyp/Estradiol Cyp Injection Due to Sterility Concerns
FDA (Drugs) · 2019-07-17

Same hazard · sterility