Class I - Dangerous
Lack of Assurance of Sterility.
PFIZER
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Subpotent drug
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations; particulates identified during visual inspection
Discoloration; discolored solution from cracked vials
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class I - Dangerous
Presence of particulate matter: glass
Presence of Particulate Matter; identified as glass
Presence of Particulate Matter; identified as glass
Presence of Particulate Matter; identified as glass
Presence of Particulate Matter: identified as glass.
Presence of Particulate Matter: identified as glass.
Presence of Particulate Matter: identified as glass.
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Lack of assurance of sterility: Bags have the potential to leak.
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Presence of particulate matter
Presence of particulate matter: particulate identified as a beetle.
Class I - Dangerous
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class I - Dangerous
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class I - Dangerous
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class I - Dangerous
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class I - Dangerous
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class I - Dangerous
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class I - Dangerous
Lack of sterility assurance: bag has the potential to leak.
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class I - Dangerous
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I - Dangerous
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Failed Dissolution Specifications
Presence of Particulate Matter: particulate matter identified after reconstitution.
Class I - Dangerous
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or expiration date.
Class I - Dangerous
Lack of Assurance of Sterility: Bag has the potential to leak.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class I - Dangerous
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Lack of Assurance of Sterility: Bags have the potential to leak.
Lack of Assurance of Sterility: Bags have the potential to leak.
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Presence of Particulate Matter; glass particulates
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class I - Dangerous
Superpotent Drug.
The firm received complaints of the wrap coming apart and leaking granular material
The firm received complaints of the wrap coming apart and leaking granular material
The firm received complaints of the wrap coming apart and leaking granular material
Lack of assurance of sterility: loss of container integrity.
Class I - Dangerous
CGMP Deviations; rejected product was used to manufacture final bulk lot
Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
Class I - Dangerous
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Class I - Dangerous
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class I - Dangerous
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I - Dangerous
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class I - Dangerous
Presence of Particulate Matter: glass particulate found in vial
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Failed Dissolution Specifications
Failed Dissolution Specifications
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Superpotent
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Class I - Dangerous
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Class I - Dangerous
Labeling: Label Mix-Up
Class I - Dangerous
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class I - Dangerous
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Failed Dissolution Specification
Class I - Dangerous
Subpotent Drug