The Recall Desk
ModerateFDA (Drugs)·D-1032-2015·Announced 2015-05-20

Carvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns

Health Innovations Pharmacy is recalling Carvedilol 1.25 mg/mL due to quality control issues affecting sterility and stability data.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves quality control issues regarding sterility and stability without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Health Innovations Pharmacy, Inc is recalling Carvedilol 1.25 mg/mL. The recall was initiated due to lack of assurance of sterility and stability data that supports the product's expiry date.

Recent inspection observations identified certain quality control procedures that present a risk to sterility and quality assurance. The recall covers all lots of the product distributed in 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
Carvedilol 1.25 mg/mL, 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 →