Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns
Trinity Care Solutions is recalling Cefepime 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 Cefepime 1 gm/100 mL 0.9%NS for parenteral use. The recall affects 52 units distributed in Florida, specifically prescription lots # 29011, # 29141, and # 29171 with expiration dates in May 2014.
The recall was initiated due to a lack of assurance of sterility. This decision follows concerns regarding 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 products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 52
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 # 29011
- Exp 05/21/14
- Rx # 29141
- Exp 05/22/14
- Rx # 29171
- Exp 05/20/14
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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