💊 Drugs • 11,927 recalls
ImprimisRx CA, Inc.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
ImprimisRx CA, Inc.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Mckesson Packaging Services
Failed moisture limits: Out of specification for moisture content.
Defective container: Oral solution leaking from container.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Amphastar Pharmaceuticals
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Labeling: Label Mixup; potentially mislabeled
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Labeling: Label Mixup; potentially mislabeled
Labeling: Label Mixup; potentially mislabeled
Labeling: Label Mixup; potentially mislabeled
Labeling: Label Mixup; potentially mislabeled
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Presence of Particulate Matter; stainless steel
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Crystallization with subpotent out of specification assay results for chlorhexidine.
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
DYNAMIC TECHNICAL FORMULATIONS
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.