Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 C...

FDA Drug Recall #D-0336-2015 — Class II — December 15, 2014

Recall Summary

Recall Number D-0336-2015
Classification Class II — Moderate risk
Date Initiated December 15, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Actavis Elizabeth LLC
Location Elizabeth, NJ
Product Type Drugs
Quantity 10,857 Bottles

Product Description

Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.

Reason for Recall

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

Distribution Pattern

Puerto Rico

Lot / Code Information

Lot #s: a) G01889A2 Exp 06/2015, b) G01942A1 Exp 08/2015

Other Recalls from Actavis Elizabeth LLC

Recall # Classification Product Date
D-0143-2017 Class III NIFEdipine Capsules USP, 10 mg, Rx only, 100 co... Oct 6, 2016
D-0816-2016 Class II Dextroamphetamine Saccharate, Amphetamine Aspar... Feb 16, 2016
D-0815-2016 Class II Dextroamphetamine Saccharate, Amphetamine Aspar... Feb 16, 2016
D-0814-2016 Class II Dextroamphetamine Saccharate, Amphetamine Aspar... Feb 16, 2016
D-0813-2016 Class II Dextroamphetamine Saccharate, Amphetamine Aspar... Feb 16, 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.