Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns
Trinity Care Solutions is recalling 16 units of Vancomycin 750 mg/150mL D5W due to quality control concerns regarding sterility assurance 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 source text identifies the recall as FDA Class II and cites a lack of assurance of sterility for a parenteral (intravenous) product. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects are classified as Severe (Score 4).
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling 16 units of Vancomycin 750 mg/150mL D5W. The product is intended for parenteral use only and was distributed in Florida. The specific lot is identified by Rx # 28878 with an expiration date of 05/16/14.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. The agency has cited a lack of assurance of sterility as the primary reason for the action. 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 immediately. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
- Category
- Drug — Antibiotic
- Affected units
- 16
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 # 28878
- Exp 05/16/14
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.
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 ANA Kit 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 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
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX 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 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
- SevereVancomycin Recall Due to Sterility Concerns at Compounding Pharmacy
FDA (Drugs) · 2013-07-10
- HighVancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
- HighVancomycin Ophthalmic Solutions Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-02-01
- SevereWalter's Pharmacy Recalls Vancomycin Solution Due to Sterility Concerns
FDA (Drugs) · 2016-04-06
- SevereVancomycin Ophthalmic Solution Recalled Due to Sterility Concerns
FDA (Drugs) · 2022-03-23
- SevereVancomycin Eye Drops Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12