Trinity Care Solutions Recalls Ceftriaxone Due to Sterility Concerns
Trinity Care Solutions is recalling 31 units of Ceftriaxone 2 gm/100 mL 0.9%NS in Florida due to quality control concerns regarding 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 assurance of sterility in a parenteral (injectable) drug, which poses a significant risk of serious health consequences if contaminated.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 31 units of Ceftriaxone 2 gm/100 mL 0.9%NS. The affected products are identified by prescription numbers 29038, 29204, and 29161, with discard dates ranging from May 5, 2014, to May 23, 2014. The recall is limited to the state of Florida.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, there is a lack of assurance of sterility for the sterile products compounded by the pharmacy. The FDA has classified this recall as Class II.
Patients who have received these specific prescription numbers should contact their healthcare provider or the pharmacy for further instructions. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 31
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 (6)
- Rx # 29039
- Exp 05/05/14 & 05/20/14
- Rx # 29204
- Exp 05/23/14
- Rx # 29161
- Exp 05/19/14
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.
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