The Recall Desk
SevereFDA (Drugs)·D-866-2013·Announced 2013-08-21

Pallimed Solutions Recalls Dexamethasone PF Due to Sterility Concerns

Pallimed Solutions is recalling Dexamethasone PF compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and 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, which corresponds to a 'Severe' rating under the rubric for significant health risks such as sterility failures in compounded drugs.

Plain-English summary

Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Dexamethasone PF. The recall covers all lots within their expiry dates and was distributed nationwide.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. These findings specifically impacted the assurance of sterility for the compounded product.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Manufacturer
Pallimed Solutions

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 within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 25 recalled by Pallimed Solutions 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 25 products in this recall →