The Recall Desk
SevereFDA (Drugs)·D-1108-2014·Announced 2014-03-12

Dexamethasone phosphate injection recalled for lack of sterility assurance

Natures Pharmacy & Compounding Center is recalling all lots of Dexamethasone phosphate 24mg/ml injection due to quality control concerns 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 recall is classified as FDA Class II and involves a lack of sterility assurance in a sterile injectable product, which presents a significant risk of serious injury or death if contaminated, fitting the 'Severe' criteria for significant injury risk or structural/quality defects in high-risk medical products.

Plain-English summary

Natures Pharmacy & Compounding Center is recalling all lots of Dexamethasone phosphate 24mg/ml injection that are not expired. The recall is limited to North Carolina (NC).

The recall was initiated due to a lack of sterility assurance. This issue stems from quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection. The agency has classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Dexamethasone phosphate 24mg/ml inj.

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 →