Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile....
FDA Drug Recall #D-1480-2016 — Class II — June 29, 2016
Recall Summary
| Recall Number | D-1480-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 29, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Isomeric Pharmacy Solution, LLC |
| Location | Salt Lake City, UT |
| Product Type | Drugs |
| Quantity | 274 multdose vials |
Product Description
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
Reason for Recall
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Distribution Pattern
Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
Lot / Code Information
Lots# 03045 and 03046; Exp. 10/16
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
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.