Class II · Moderate risk
Mimvey Lo (estradiol and norethindrone acetate tablets USP)
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Glipizide extended-release tablets
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%
CGMP Deviations
Class II · Moderate risk
MakeSense PHARMA
CGMP Deviations
Class II · Moderate risk
Calcipotriene Cream 0.0005%
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class II · Moderate risk
glipiZIDE Extended-Release Tablets
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Class II · Moderate risk
Potassium Chloride Oral Solution
Defective Container: Leakage of unit dose cups that may occur at the seal.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Phenytoin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Metoclopramide Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Nystatin Oral Suspension
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Duopa (carbidopa and levodopa enteral suspension)
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Class II · Moderate risk
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles
Failed Dissolution Specifications