Sciegen Pharmaceuticals Inc

Complete recall history across all FDA and CPSC categories — 7 total recalls

Sciegen Pharmaceuticals Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (7)

FDA drug safety enforcement actions by Sciegen Pharmaceuticals Inc

Date Product Reason Class
Feb 17, 2023 Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured... Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Ga... Class III
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-... Class II
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-... Class II
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured b... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-... Class II
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-... Class II
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30),... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-... Class II
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-11... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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