The Recall Desk
SevereFDA (Drugs)·D-1464-2014·Announced 2014-07-30

Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

Trinity Care Solutions is recalling Desferal sterile compounds in Florida due to quality control concerns identified during an FDA inspection.

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 assurance of sterility in a parenteral product, which poses a significant risk of serious injury or death from infection.

Plain-English summary

Trinity Care Solutions, operating as Franck's Lab Inc, is recalling Desferal 2 gm/8 mL Sterile Water compounded for parenteral use. The recall covers 2 units with Rx # 27767 and an expiration date of 05/23/14. The product was distributed in Florida.

The recall was initiated due to a lack of assurance of sterility. This action follows concerns associated with quality control procedures observed during a recent FDA inspection. All lots of sterile products compounded by the pharmacy within their expiry dates are subject to this recall.

Consumers and healthcare providers in Florida who possess this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14
Affected units
2

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 (2)

  • Rx # 27767
  • Exp 05/23/14

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 30 recalled by Franck's Lab Inc dba Trinity Care 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 30 products in this recall →