Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadi...
FDA Drug Recall #D-1645-2012 — Class III — July 25, 2012
Recall Summary
| Recall Number | D-1645-2012 |
| Classification | Class III — Low risk |
| Date Initiated | July 25, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Health Packaging |
| Location | Columbus, OH |
| Product Type | Drugs |
| Quantity | 1,170 cartons |
Product Description
Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311
Reason for Recall
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: 113032A, 113032B, Exp 04/13
Other Recalls from American Health Packaging
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0880-2022 | Class III | Nitrofurantoin Capsules, USP (Monohydrate/Macro... | May 3, 2022 |
| D-0790-2022 | Class III | Cyanocobalamin Injection, USP, 1000 mcg per mL,... | Apr 12, 2022 |
| D-0652-2022 | Class II | Oxycodone Hydrochloride Oral Solution, USP (C-I... | Feb 22, 2022 |
| D-0451-2022 | Class II | Metoprolol Succinate Extended-Release Tablets, ... | Dec 20, 2021 |
| D-0020-2022 | Class II | GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 ... | Sep 17, 2021 |
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.