Prescription Drugs

CGMP deviations.

Discoloration and failed pH specifications

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

Incorrect Labeling: Incorrect lot number on secondary packaging

Presence of Particulate Matter - found in reserve sample vials at the firm.

CGMP deviations: Lack of potency testing.

Failed Dissolution Specifications

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.

CGMP deviations: Lack of potency testing.

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.

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.

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