Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
Product description
Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
Lot numbers, UPCs & expiration codes
Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015"
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-0728-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 2, 2016
- FDA report date
- Mar 2, 2016
- Quantity
- 114 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Isomeric Pharmacy Solution, LLC
Original FDA data
Every field from FDA enforcement report D-0728-2016, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 73207
- Address
- 2401 S Foothill Dr
- Code information
- Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015"
- Postal code
- 84109-1479
- Report date
- Mar 2, 2016
- Product type
- Drugs
- Recall number
- D-0728-2016
- Classification
- Class III
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Product quantity
- 114 vials
- Termination date
- May 3, 2016
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 25, 2016