Methylprednisolone Base active pharmaceutical ingredient packaged in varying grams or kg in bags ...
FDA Drug Recall #D-792-2015 — Class II — November 14, 2014
Recall Summary
| Recall Number | D-792-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 14, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Attix Pharmaceuticals |
| Location | Toronto |
| Product Type | Drugs |
| Quantity | 150 grams |
Product Description
Methylprednisolone Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Reason for Recall
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Distribution Pattern
Nationwide to compounding pharmacies and research organizations.
Lot / Code Information
All lots repackaged and distributed between 01/05/12 to 02/12/15
Other Recalls from Attix Pharmaceuticals
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-798-2015 | Class II | Miltefosine active pharmaceutical ingredient pa... | Nov 14, 2014 |
| D-533-2015 | Class II | Azithromycin Dihydrate active pharmaceutical in... | Nov 14, 2014 |
| D-549-2015 | Class II | Bromocriptine Mesylate active pharmaceutical in... | Nov 14, 2014 |
| D-645-2015 | Class II | Droperidol active pharmaceutical ingredient pac... | Nov 14, 2014 |
| D-776-2015 | Class II | Meloxicam active pharmaceutical ingredient pack... | Nov 14, 2014 |
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.