FDAFDA · Food and drugs·Recall number D-0526-2022
Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
Published February 16, 2022 · Recall initiated: January 26, 2022
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Distributor
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Lot
- Product Codes: C119L Bulk Lots: 18K028
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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