Class I - Dangerous
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Dr. Reddy'S Laboratories
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Tablet/Capsule Specifications
Class I - Dangerous
Failed Impurities/Degradation Specification
Class I - Dangerous
Failed Impurities/Degradation Specification
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class I - Dangerous
Presence of foreign substance.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Related Substances
Lack of Assurance of Sterility: Leaking vials
Class I - Dangerous
Failed Impurities/Degradation Specifications
Sub-potent Drug; powder discoloration associated with decreased potency
Sub-potent Drug; powder discoloration associated with decreased potency
Class I - Dangerous
Misprint on tablet
Class I - Dangerous
Misprint on tablet
Class I - Dangerous
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class I - Dangerous
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class I - Dangerous
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Failed dissolution specifications
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
FAILED DISSOLUTION SPECIFICATIONS
FAILED DISSOLUTION SPECIFICATIONS
Failed Dissolution Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Class I - Dangerous
Failed Dissolution Specifications; during long term stability testing.
Failed Dissolution Specifications; during long term stability testing.
Class I - Dangerous
Failed stability specifications
Class I - Dangerous
Failed stability specifications
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class I - Dangerous
Failed stability specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Subpotent drug
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed dissolution specifications
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class I - Dangerous
Failed Tablet/Capsule Specification: Some tablets are shaved
Class I - Dangerous
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class I - Dangerous
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class I - Dangerous
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Failed Dissolution Specifications
Class I - Dangerous
Discoloration: product contains brown pellets
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
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
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class I - Dangerous
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class I - Dangerous
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
Class I - Dangerous
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.