Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tabl...
FDA Drug Recall #D-0215-2017 — Class I — August 19, 2016
Recall Summary
| Recall Number | D-0215-2017 |
| Classification | Class I — Serious risk |
| Date Initiated | August 19, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Impax Laboratories, Inc. |
| Location | Hayward, CA |
| Product Type | Drugs |
| Quantity | 3,074 boxes (30 count boxes) |
Product Description
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Reason for Recall
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Distribution Pattern
Distributed Nationwide
Lot / Code Information
Lot Number 502240, expiry date 11/2017
Other Recalls from Impax Laboratories, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0820-2016 | Class III | Fenofibrate Capsules (Micronized) 134 mg, 500-c... | Mar 17, 2016 |
| D-0821-2016 | Class III | Fenofibrate Capsules (Micronized) 200 mg, 500-c... | Mar 17, 2016 |
| D-0825-2016 | Class II | Dextroamphetamine Sulfate Tablets USP, 10 mg, 1... | Mar 14, 2016 |
| D-0826-2016 | Class II | Dextroamphetamine Sulfate Tablets USP, 5 mg, 10... | Mar 14, 2016 |
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.