💊 Drugs • 11,927 recalls
Mallinckrodt Hospital Products
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Labeling: Incorrect or Missing Package Insert
CGMP Deviations: potential presence of Burkholderia cepacia complex
Henry Schein Inc. and Glove Club HSI Gloves
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Today The World
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Today The World
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
IntegraDose Compounding Services
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
The Harvard Drug Group LLC
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Dr. Reddy's Laboratories
Misprint on tablet
Amerisource Health Services
CGMP Deviations
Dr. Reddy's Laboratories
Misprint on tablet
Amneal Pharmaceuticals of New York
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Amerisource Health Services
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Golden State Medical Supply
Failed Dissolution Specifications
Failed Dissolution Specifications