Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC,...
FDA Drug Recall #D-0042-2015 — Class II — May 22, 2014
Recall Summary
| Recall Number | D-0042-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 22, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aidarex Pharmaceuticals LLC |
| Location | Corona, CA |
| Product Type | Drugs |
| Quantity | 531 bottles |
Product Description
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
Reason for Recall
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Distribution Pattern
Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS
Lot / Code Information
Lot 39661-3 Exp. 07/15
Other Recalls from Aidarex Pharmaceuticals LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0992-2018 | Class III | Enalapril Maleate, USP 5MG, 30-count bottle, RX... | Jun 27, 2018 |
| D-0990-2018 | Class III | Enalapril Maleate, USP 2.5MG, 90-count bottle, ... | Jun 27, 2018 |
| D-0991-2018 | Class III | Enalapril Maleate, USP 5MG, 90-count bottle, RX... | Jun 27, 2018 |
| D-0810-2018 | Class III | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Apr 10, 2018 |
| D-1162-2017 | Class III | Phentermine, USP Capsules, 15 mg, 30 count bott... | Sep 5, 2017 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.