Why it was recalled
CGMP Deviations
Product description
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
Lot numbers, UPCs & expiration codes
Lot #08016; Exp. 03/14/17 Lot #08018; Exp. 03/15/17 Lot #08023; Exp. 03/22/17 Lot #08026; Exp. 03/19/17 Lot #08033; Exp. 03/28/17 Lot #09004; Exp. 04/03/17 Lot #11014; Exp. 06/10/17 Lot #11031; Exp. 06/20/17
Where it was sold
Nationwide
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-0518-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2017
- FDA report date
- Mar 22, 2017
- Quantity
- 6,999 single-use vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Isomeric Pharmacy Solution, LLC
Original FDA data
Every field from FDA enforcement report D-0518-2017, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 76676
- Address
- 2401 S Foothill Dr
- Code information
- Lot #08016; Exp. 03/14/17 Lot #08018; Exp. 03/15/17 Lot #08023; Exp. 03/22/17 Lot #08026; Exp. 03/19/17 Lot #08033; Exp. 03/28/17 Lot #09004; Exp. 04/03/17 Lot #11014; Exp. 06/10/17 Lot #11031; Exp. 06/20/17
- Postal code
- 84109-1479
- Report date
- Mar 22, 2017
- Product type
- Drugs
- Recall number
- D-0518-2017
- Classification
- Class II
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Product quantity
- 6,999 single-use vials
- Termination date
- May 25, 2017
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 8, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2017