Reported Jan 14, 2015 · Terminated

Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle,…

Actavis Elizabeth LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Actavis Elizabeth LLC · 200 Elmora Ave · Elizabeth, NJ · 07202-1106

Is this the product you have?

    • Gabapentin Capsules
    • USP
    • 100 mg
    • Rx Only
    • a) 100 capsules per bottle
    • NDC 45963-555-11
    • b) 500 Capsules per bottle
    • NDC 45963-555-50
  • Manufactured byActavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India
  • Distributed byActavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA
Lot codes and dates
    • Lot #s: a) G01966A1
    • Exp 10/2015
    • b) G02004A1
    • Exp 03/2016
Amount recalled
29,622 Bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 20, 2015 · Data as of Sep 19, 7:15 PM UTC

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