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.
Reported: January 15, 2020 Initiated: January 7, 2020 #D-0649-2020
Product Description
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.
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Details
- Recalling Firm
- Appco Pharma LLC
- Units Affected
- 624 bottes
- Distribution
- Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
- Location
- Piscataway, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Appco Pharma LLC. Units affected: 624 bottes.
Why was this product recalled? ▼
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2020. Severity: Moderate. Recall number: D-0649-2020.
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