GABAPENTIN

Generic: GABAPENTIN

Zhejiang Yongtai Pharmaceutical Co.Manufacturer

ORALRoute

GABAPENTINActive Substance

2020-08-17Original Approval

GABAPENTIN is FDA application ANDA213603, sponsored by ZHEJIANG YONGTAI. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2023-02-17

Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge

Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg

Class II2020-03-18

Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class II2025-10-10

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmac

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine

Class II2025-03-13

Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh

CGMP Deviations

Class III2025-03-04

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC

Cross Contamination

Class III2013-04-05

Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-1

Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off -

Class II2014-12-15

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

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaki

Class III2023-04-24

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu

Product mixup: one foreign tablet found in product.

Class III2020-05-14

Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term s

Class II2014-12-15

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

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaki

GABAPENTIN

Recalls

Top Reported Reactions