Agency classClass IIOur severity:Severe FDA (Drugs)·D-0998-2015·Announced 2015-05-20

Health Innovations Pharmacy Recalls 17-HP Hydroxyprogesterone Injection Due to Sterility Concerns

Health Innovations Pharmacy is recalling 17-HP Hydroxyprogesterone 250mg/1ml Injection because inspection findings indicate a lack of assurance regarding sterility and stability data.

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 involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the agency classification and the nature of the sterility risk in an injectable drug align with the Severe criteria for Class II recalls where risk is present.

Plain-English summary

Health Innovations Pharmacy, Inc. is recalling 17-HP Hydroxyprogesterone 250mg/1ml Injection. The recall was initiated due to recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

The source text indicates that the lack of assurance of sterility and stability data does not support the product's expiry. The recall covers all lots of the product. Distribution is listed as North Carolina (NC).

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Manufacturer: Health Innovations Pharmacy, Inc
Category: Drug — Injectable
Hazard: sterility
quality-assurance

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 1 state:

Part of a larger recall action

This product is one of 65 recalled by Health Innovations Pharmacy, 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 65 products in this recall →

Same manufacturer · Health Innovations Pharmacy, Inc

See all →

Moderate
Carvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
High
Progest Cream Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
High
Health Innovations Pharmacy Recalls Phospholine Iodide Eye Drops
FDA (Drugs) · 2015-05-20
High
Nortriptyline Suspension Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
High
Health Innovations Pharmacy Recalls Naltrexone Capsules Due to Sterility Concerns
FDA (Drugs) · 2015-05-20

Same hazard · sterility