Late Recalls

Wed Sep 10 2025

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

0

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Wed Sep 10 2025

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

0

KLEENFOAM (OTC ANTIMICROBIAL DRUG PRODUCT)

Wed Sep 10 2025

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

0

Wed Sep 10 2025

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

0

DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT)

Wed Sep 10 2025

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

0

PERIGIENE (ANTIMICROBIAL DRUG PRODUCT)

Wed Sep 10 2025

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

0

Wed Sep 10 2025

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

0

Wed Sep 10 2025

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

0

LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)

DERMASARRA (OTC TOPICAL ANALGESIC DRUG PRODUCTS)

Wed Sep 10 2025

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

0

Wed Sep 03 2025

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

0

INCONTROL ALCOHOL (ISOPROPYL ALCOHOL)

Wed Sep 03 2025

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

0

Wed Sep 03 2025

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

0

Wed Sep 03 2025

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

0

CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)

Wed Sep 03 2025

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

1

0

Wed Sep 03 2025

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

0

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

0

ACETAMINOPHEN

Wed Sep 03 2025

Discoloration

0

GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER (ISOPROPYL ALCOHOL)

Wed Sep 03 2025

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

0

MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)

Wed Sep 03 2025

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

0

EPINEPHRINE

Wed Aug 27 2025

Lack of Assurance of Sterility.

0

SODIUM BICARBONATE

Wed Aug 27 2025

Lack of Assurance of Sterility.

0

Sensodyne PRONAMEL

Wed Aug 27 2025

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

0

ALBUTEROL SULFATE

Wed Aug 27 2025

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

1

0

CARVEDILOL

Wed Aug 27 2025

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

0

TAVABOROLE

Wed Aug 27 2025

Discoloration

0

BZK Antiseptic Towelette

Wed Aug 27 2025

Lack of Assurance of Sterility.

0

BELSOMRA (SUVOREXANT)

Wed Aug 20 2025

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

0

LEVOXYL (LEVOTHYROXINE SODIUM)

Wed Aug 20 2025

Subpotent drug

0

LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)

Wed Aug 20 2025

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

0

METOPROLOL TARTRATE

Wed Aug 20 2025

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

0

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Wed Aug 20 2025

Failed Dissolution Specifications: low dissolution results

0

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Wed Aug 20 2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

0

CARVEDILOL

Wed Aug 20 2025

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

0

SODIUM CHLORIDE

Wed Aug 20 2025

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

2

0

CARVEDILOL

Wed Aug 20 2025

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

0

METOPROLOL TARTRATE

Wed Aug 20 2025

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

0

CARVEDILOL

Wed Aug 20 2025

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

0

THEOPHYLLINE

Wed Aug 20 2025

Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

0