FDAFDA · Food and drugs·Recall number D-0855-2020
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Published February 19, 2020 · Recall initiated: February 12, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide within the United States.
- UPC
- 0368180247067
- Lot
- Lot #: H900330, exp. date 11/2020.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.