The Recall Desk
SevereFDA (Drugs)·D-1001-2015·Announced 2015-05-20

Methylcobalamin Injection Recalled for Sterility and Stability Concerns

Health Innovations Pharmacy is recalling Methylcobalamin 1000 mcg/mL Injection due to quality control issues affecting 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 classification is FDA Class II. The hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury (e.g., infection) if administered, fitting the criteria for a Severe rating.

Plain-English summary

Health Innovations Pharmacy, Inc. is recalling Methylcobalamin 1000 mcg/mL Injection. The recall is being conducted because recent inspection observations identified a lack of assurance regarding sterility and stability data. These quality control issues present a risk to the sterility and overall quality assurance of the product.

The recall covers all lots of the product. The distribution pattern is listed as North Carolina (NC). The source text does not specify the exact number of units affected or specific dates of distribution.

Consumers and healthcare providers should stop using the recalled product and contact Health Innovations Pharmacy, Inc. at (910) 246-5155 or visit 295 Pinehurst Ave, Southern Pines, NC 28387 for further instructions.

The recalled product

Product
Methylcobalamin 1000 mcg/mL 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 →