Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge
Summary
The FDA issued a Class III for Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by by Sciegen Pharmaceuticals Inc. Reason: Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles..
Details
Source
Drug Recall
External ID
D-0354-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
Product Description
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
Lot/Code Info: Lot # G177092, Exp. 11/24
Quantity Affected: 4,392 bottles
Reason for Recall
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-17
Company
Hauppauge, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sciegen Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sciegen Pharmaceuticals Inc have FDA actions?
This is the only FDA action we have on record for Sciegen Pharmaceuticals Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0354-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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