Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Magnesium Sulfate 7-Hydrate
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Class III · Low risk
Epsom Salt
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
Class III · Low risk
Meclizine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Duloxetine Delayed-release Capsules
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Class III · Low risk
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic Topical
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
Donnatal
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Class III · Low risk
Fenofibric Acid Tablets 105 mg
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class III · Low risk
Fenofibric Acid Tablets
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class III · Low risk
Amidate (Etomidate Injection, USP)
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Class III · Low risk
Cetirizine HCl 10 mg Tablet
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk
ClomiPHENE CITRATE Tablets
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class III · Low risk
Bravelle 75 IU
Subpotent Drug
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Falied pH specification
Class III · Low risk
Lamivudine Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Class III · Low risk
Hydrocortisone and Acetic Acid Otic Solution
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.