The Recall Desk
SevereFDA (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.

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 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

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 →