💊 Drugs • 12,141 recalls
Complete Pharmacy and Medical Solutions
CGMP deviations: Lack of potency testing.
Failed Dissolution Specifications
Complete Pharmacy and Medical Solutions
CGMP deviations: Lack of potency testing.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Complete Pharmacy and Medical Solutions
CGMP deviations: Lack of potency testing.
Complete Pharmacy and Medical Solutions
CGMP deviations: Lack of potency testing.
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Defective container: Customer complaints for oral solution leaking from bottles.
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
US Compounding
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Nostrum Laboratories
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
SCA Pharmaceuticals
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
SCA Pharmaceuticals
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit