The Recall Desk
SevereFDA (Drugs)·D-1123-2014·Announced 2014-03-12

Methotrexate Intraocular Recall Due to Sterility Assurance Concerns

Natures Pharmacy & Compounding Center is recalling all unexpired lots of Methotrexate Intraocular 400mcg 0.1cc due to quality control issues affecting sterility assurance.

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. The hazard involves a lack of sterility assurance in a sterile injectable product, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk structural/quality defects.

Plain-English summary

Natures Pharmacy & Compounding Center is recalling all unexpired lots of Methotrexate Intraocular 400mcg 0.1cc. The recall is limited to the state of North Carolina (NC).

The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy's sterile compounding processes.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Methotrexate Intraocular 400mcg 0.1cc

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 lot numbers within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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 48 products in this recall →