Trinity Care Solutions Recalls Cefazolin Due to Sterility Concerns
Trinity Care Solutions is recalling 21 units of Cefazolin 1 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 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 21 units of Cefazolin 1 gm/100 mL 0.9%NS. The product is identified by Rx # 28837 and has an expiration date of 04/11/14. The recall is limited to distribution 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 are subject to this recall.
Consumers and healthcare providers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 21
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 # 28837
- Exp 04/11/14
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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