FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Glyburide Metformin Tablets
Status: Discontinuation
»Therapeutic Categories: Endocrinology/Metabolism

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Impax Laboratories (New 08/25/2017)

Company Contact Information:
877-994-6729

Presentation Posting Date Related Information
1.25 mg/250 mg; 100 tablets/bottle (NDC 0115-1648-01) 08/25/2017 A business decision was made to discontinue manufacture of the drug product. This product discontinuation is not related to product quality, safety, or efficacy. The anticipated final date for marketing is September 2017.
1.25 mg/250 mg; 500 tablets/bottle (NDC 0115-1648-02) 08/25/2017 A business decision was made to discontinue manufacture of the drug product. This product discontinuation is not related to product quality, safety, or efficacy. The anticipated final date for marketing is September 2017.
2.5 mg/500 mg; 100 tablets/bottle (NDC 0115-1649-01) 08/25/2017 A business decision was made to discontinue manufacture of the drug product. This product discontinuation is not related to product quality, safety, or efficacy. The anticipated final date for marketing is September 2017.
2.5 mg/500 mg; 500 tablets/bottle (NDC 0115-1649-02) 08/25/2017 A business decision was made to discontinue manufacture of the drug product. This product discontinuation is not related to product quality, safety, or efficacy. The anticipated final date for marketing is September 2017.
5 mg/500 mg; 100 tablets/bottle (NDC 0115-1650-01) 08/25/2017 A business decision was made to discontinue manufacture of the drug product. This product discontinuation is not related to product quality, safety, or efficacy. The anticipated final date for marketing is September 2017.
5 mg/500 mg; 500 tablets/bottle (NDC 0115-1650-02) 08/25/2017 A business decision was made to discontinue manufacture of the drug product. This product discontinuation is not related to product quality, safety, or efficacy. The anticipated final date for marketing is September 2017.

Zydus Pharmaceuticals USA Inc. (New 05/22/2017)

Company Contact Information:
877-993-8779

Presentation Posting Date Related Information
Glyburide and Metformin Hydrochloride Tablets, USP, 1.25mg/250mg, 100s (NDC 68382-653-01) 05/22/2017 The product is being discontinued because of commercial reasons.
Glyburide and Metformin Hydrochloride Tablets, USP, 2.5mg/250mg, 100s (NDC 68382-654-01) 05/22/2017 The product is being discontinued because of commercial reasons.
Glyburide and Metformin Hydrochloride Tablets, USP, 2.5mg/250mg, 500s (NDC 68382-654-05) 05/22/2017 The product is being discontinued because of commercial reasons.
Glyburide and Metformin Hydrochloride Tablets, USP, 5mg/500mg, 100s (NDC 68382-655-01) 05/22/2017 The product is being discontinued because of commercial reasons.
Glyburide and Metformin Hydrochloride Tablets, USP, 5mg/500mg, 500s (NDC 68382-655-05) 05/22/2017 The product is being discontinued because of commercial reasons.

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