Class I - Dangerous
Lack of Assurance of Sterility
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Failed Stability Specifications
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class I - Dangerous
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class I - Dangerous
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Out of specification results observed in dissolution during long term stability testing.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
CGMP deviations
Class I - Dangerous
Defective container: Out of specification for container integrity leading to bottles leaking.
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class I - Dangerous
Failed Impurities/Degradation Specifications
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.