Tobramycin 300 mg/7.5 mL Syringe recall: Sterility Concern
Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503…
Why was Tobramycin 300 mg/7.5 mL Syringe recalled?
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Rx # 28503, Exp 02/27/14
- Product
- Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503…
- Recalling firm
- Franck's Lab Inc dba Trinity Care Solutions
- Quantity
- 14 units
- Distribution
- Florida
- Recall date
- July 30, 2014
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)