Why it was 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.
Product description
Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
Lot numbers, UPCs & expiration codes
Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15
Where it was sold
Florida
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1468-2014
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 15, 2014
- FDA report date
- Jul 30, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Franck's Lab Inc dba Trinity Care Solutions
Original FDA data
Every field from FDA enforcement report D-1468-2014, exactly as published.
Show all FDA fields
- City
- Ocala
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 68497
- Address
- 202 SW 17th St Suite C
- Code information
- Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15
- Postal code
- 34471-8138
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1468-2014
- Classification
- Class II
- Recalling firm
- Franck's Lab Inc dba Trinity Care Solutions
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
- Distribution pattern
- Florida
- Recall initiation date
- May 15, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 24, 2014