The Recall Desk
SevereFDA (Drugs)·D-1482-2014·Announced 2014-07-30

Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns

Trinity Care Solutions is recalling 12 units of Ceftriaxone 1 gm/50 mL D5W 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 FDA classified this recall as Class II, and the hazard involves a lack of assurance of sterility in a parenteral product, which poses a significant risk of infection.

Plain-English summary

Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 12 units of Ceftriaxone 1 gm/50 mL D5W. The affected products are identified by Rx # 29190 (Exp 05/23/14) and Rx # 29068 (Exp 05/18/14). These sterile products were 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 should stop using the affected Ceftriaxone products immediately. The FDA has classified this recall as Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14
Affected units
12

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 (4)

  • Rx # 29190
  • Exp 05/23/14
  • Rx # 29068
  • Exp 05/18/14

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 →