FDAFDA · Food and drugs·Recall number D-0012-2021
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Published September 16, 2020 · Recall initiated: August 24, 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
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CEPHALEXIN
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide in the U.S. and Puerto Rico.
- UPC
- 0300934175738
- Lot
- Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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