Status
Ongoing
Drug Enforcement D-0320-2025
CGMP Deviations
Classification
Class II
Report Date
April 16, 2025
Termination Date
—
Product Information
- Product description
- Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.
- Product quantity
- N/A
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0320-2025
- Event ID
- 96474
- Recall initiation date
- March 13, 2025
- Center classification date
- April 8, 2025
- Code info
- Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25
- More code info
- —