The Recall Desk
SevereFDA (Drugs)·D-1038-2015·Announced 2015-05-20

Health Innovations Pharmacy Recalls Rifampin Suspension Due to Sterility Concerns

Health Innovations Pharmacy is recalling all lots of Rifampin 25 mg/1 mL Suspension due to inspection findings 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving risks to sterility and quality assurance.

Plain-English summary

Health Innovations Pharmacy, Inc. is recalling all lots of Rifampin 25 mg/1 mL Suspension. The recall was initiated following recent inspection observations associated with certain quality control procedures. These observations present a risk to the sterility and quality assurance of the product, as the available stability data does not support the stated expiry dates.

The recall is limited to the state of North Carolina. 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
Rifampin 25 mg/1 mL Susp, 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 →