The Recall Desk
HighFDA (Drugs)·D-1031-2015·Announced 2015-05-20

Spironolactone Suspension Recalled for Sterility and Stability Concerns

Health Innovations Pharmacy is recalling Spironolactone 5 mg/mL Suspension due to quality control issues affecting sterility and stability data.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility and stability issues) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Health Innovations Pharmacy, Inc. is recalling Spironolactone 5 mg/mL Suspension. The recall was initiated because recent inspection observations identified deficiencies in certain quality control procedures. These deficiencies present a risk to the sterility and quality assurance of the product, as stability data does not support the assigned expiry date.

The recall covers all lots of the product. Distribution was limited to North Carolina. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of this product.

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

The recalled product

Product
Spironolactone 5 mg/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 →