Recalls / Class III
Class IIID-0728-2016
Product
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
- Affected lot / code info
- Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015"
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.
Recalling firm
- Firm
- Isomeric Pharmacy Solution, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2401 S Foothill Dr, N/A, Salt Lake City, Utah 84109-1479
Distribution
- Quantity
- 114 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-02-02
- FDA classified
- 2016-02-25
- Posted by FDA
- 2016-03-02
- Terminated
- 2016-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0728-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.