Trinity Care Solutions Recalls ANA Kit Due to Sterility Concerns
Trinity Care Solutions is recalling ANA Kits due to quality control concerns identified during an FDA inspection regarding the assurance of sterility.
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 product intended for parenteral use, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Trinity Care Solutions, doing business as Franck's Lab Inc, is recalling ANA Kits. The recall is initiated due to a lack of assurance of sterility and concerns associated with quality control procedures observed during a recent FDA inspection.
The recall affects all lots of sterile products compounded by the pharmacy within their expiry dates. The specific product identified is the ANA Kit, manufactured by Franck's Lab Inc dba Trinity Care Solutions, located in Ocala, Florida. The product is labeled for parenteral use only and carries the Rx number 28838 with a discard date of 03/4/15.
The distribution pattern for this recall is limited to Florida. Consumers and healthcare providers should stop using the affected ANA Kits and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Affected units
- 1
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 # 28838
- Exp 03/4/15
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 →Related recalls
Same manufacturer · Franck's Lab Inc dba Trinity Care Solutions
See all →- SevereTrinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
- SevereTrinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
- SevereTrinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
- SevereTrinity Care Solutions Recalls Unasyn Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
- SevereTrinity Care Solutions Recalls Levofloxacin Due to Sterility Concerns
FDA (Drugs) · 2014-07-30
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighNavilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst NAMIC Convenience Kit Recalled Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- HighFDA Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighNavilyst NAMIC Convenience Kit Recalled for Sterility Concerns
FDA (Devices) · 2015-03-04
- HighNavilyst NAMIC Convenience Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2015-03-04
- SevereFranck's Lab Recalls Dapiprazole Ophthalmic Products Due to Sterility Concerns
FDA (Drugs) · 2012-08-22