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.
FDA Drug Recalls
142 recalls · Class III, newest first
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.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.