Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx o...
FDA Drug Recall #D-0728-2016 — Class III — February 2, 2016
Recall Summary
| Recall Number | D-0728-2016 |
| Classification | Class III — Low risk |
| Date Initiated | February 2, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Isomeric Pharmacy Solution, LLC |
| Location | Salt Lake City, UT |
| Product Type | Drugs |
| Quantity | 114 vials |
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
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.
Distribution Pattern
Nationwide
Lot / Code Information
Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015"
Other Recalls from Isomeric Pharmacy Solution, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0685-2017 | Class II | Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ In... | Apr 6, 2017 |
| D-0684-2017 | Class II | Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-D... | Apr 6, 2017 |
| D-0686-2017 | Class II | Testosterone Cypionate 200 mg/mL, Testosterone ... | Apr 6, 2017 |
| D-0683-2017 | Class II | Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl... | Apr 6, 2017 |
| D-0681-2017 | Class II | Methylprednisolone Acetate 40 mg/mL, Lidocaine ... | Apr 6, 2017 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.