Trinity Care Solutions Recalls Meropenem Due to Sterility Concerns
Trinity Care Solutions is recalling 42 units of Meropenem 1 gm/100 mL 0.9%NS due to lack of assurance of sterility 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, meeting the criteria for a Severe rating.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 42 units of Meropenem 1 gm/100 mL 0.9%NS. The product is a sterile solution intended for parenteral use only, with a discard date of May 28, 2014, and was distributed in Florida.
The recall was initiated because of 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 product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 42
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 (1)
- Rx # 29087 Exp. 5/28/2014
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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