Product Safety Recalls

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GABAPENTIN Recall D-0354-2023

Description: Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.

GABAPENTIN Recall D-0354-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0354-2023
Event ID91717
Original Package?1
Active SubstanceGABAPENTIN
Drug RouteORAL
DistributionNationwide in the USA and Puerto Rico
Quantity4,392 bottles
Recall ReasonPresence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Drug ClassificationClass III
Drug Code Info20230308
Product NDC50228-177 50228-178
Product NUIN0000175753 N0000008486
Drug UPC0350228179010 0350228179102 0350228180306
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Pharma Class (EPC)Anti-epileptic Agent [EPC]
Recall Initiation Date20230217
Report Date20230308
Classification Date20230227
Address89 Arkay Dr
Hauppauge, NY 11788-3727
United States
Recalling FirmSciegen Pharmaceuticals Inc
Initial Notification Letter
Unique Ingredient Identifier6CW7F3G59X
Drug Application NumberANDA205101
Structured Product Labeling (SPL ID)f1dbd962-5c51-1a6e-e053-2a95a90a0553
Structured Product Labeling (SPL Set ID)5ab9c18b-9568-4dcb-90b0-252aef8f8dc2
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