Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Gabapentin Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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 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.
Affected NDCs
45963-0555-11
45963-0555-50
Compare with the code on your package — it is the most precise check available.
Drug: Gabapentin Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Gabapentin NDC 45963-0555 |
100 mg/1 | Capsule Oral |
Actavis Pharma, Inc. | Rx |
- Recalling firm
- Actavis Elizabeth LLC
- NDC code
- 45963-555-11
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0338-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Gabapentin recalls
See all
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Tablets 600mg
CGMP Deviations
Other recalls by Actavis Elizabeth LLC
All 2014 recalls
Class III · Low risk
NIFEdipine Capsules USP
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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