Status
Ongoing
Drug Enforcement D-0552-2023
CGMP Deviations
Classification
Class II
Report Date
May 3, 2023
Termination Date
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Product Information
- Product description
- Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
- Product quantity
- a) 198 bottles; b) 22 bottles
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide with the United States
Location & Firm
- Recalling firm
- Northwind Pharmaceuticals LLC
- Address
-
4838 Fletcher Ave Ste 1000, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0552-2023
- Event ID
- 91944
- Recall initiation date
- March 16, 2023
- Center classification date
- April 26, 2023
- Code info
- a) Lot #: F105692201, Exp. Date 09/30/2024; F105692203, Exp. Date 02/28/2025 b) Lot #: F105692202, Exp. Date 02/28/2025
- More code info
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