Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Drugs Recalls
Prescription and over-the-counter medications
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Pain Free By Nature
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
Konsyl Pharmaceuticals
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Boehringer Ingelheim Roxane
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
Boehringer Ingelheim Roxane
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Defective container: Product distributed without inner seal on bottles.
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
Blu Pharmaceuticals
Defective container: Product distributed without inner seal on bottles.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.