FDAFDA · Food and drugs·Recall number D-0649-2020
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
Published January 15, 2020 · Recall initiated: January 7, 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: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Appco Pharma LLC
- Distributor
- Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
- Lot
- Batch # 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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