FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Levetiracetam Extended-Release Oral Tablets, USP
Status: Currently in Shortage
»Date first posted: 05/28/2019
»Therapeutic Categories: Neurology

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Apotex Corp. (Reverified 09/18/2019)

Company Contact Information:
800-706-5575

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Levetiracetam Extended-Release Tablets 500 mg (60 ct. bottle)(NDC 60505-3280-06) Limited product available
Levetiracetam Extended-Release Tablets 750 mg (60 ct. bottle)(NDC 60505-3517-06) Short-term backorder; Estimated resupply mid-October 2019

Lupin (Reverified 07/12/2019)

Company Contact Information:
866-587-4617

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500mg 60 count bottle (NDC 68180-117-07) Continuous production but will be on/off backorder Shortage of active ingredient
750mg 60 count bottle (NDC 68180-118-07) Continuous production but will be on/off backorder Shortage of active ingredient

Solco Healthcare US, LLC (New 05/28/2019)

Company Contact Information:
866-931-9829

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Levetiracetam ER Tablets, 500mg, 60’s (NDC 43547-0345-06) Long-term backorder for all skus. No estimated release date at this time.
Levetiracetam ER Tablets, 500mg, 500’s (NDC 43547-0345-50) Long-term backorder for all skus. No estimated release date at this time.
Levetiracetam ER Tablets, 750mg, 60’s (NDC 43547-0346-06) Long-term backorder for all skus. No estimated release date at this time.
Levetiracetam ER Tablets, 750mg, 500’s (NDC 43547-0346-50) Long-term backorder for all skus. No estimated release date at this time.

Sun Pharmaceutical Industries Inc. (New 05/28/2019)

Company Contact Information:
800-818-4555

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500mg tablet 60 count bottle (NDC 4733557386) Available Demand increase for the drug
750mg tablet 60 count bottle (NDC 4733557686) Available Demand increase for the drug

UCB Inc. (New 05/28/2019)

Company Contact Information:
919-767-3210

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
500mg extended-release (NDC 50474-598-66) Available
750mg extended-release (NDC 50474-599-66) Available

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