Class III · Low risk Terminated
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Reason Labeling: Incorrect or Missing Lot AND/OR Exp Date.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
HPMC Visoelastic
Reason Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
HPMC Visoelastic Topical
Reason Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
HPMC Visoelastic
Reason Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
Donnatal
Reason 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 Terminated
Fenofibric Acid Tablets 105 mg
Reason 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 Terminated
Fenofibric Acid Tablets
Reason 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 Ongoing
Amidate
Reason Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Class III · Low risk Terminated
Cetirizine HCl 10 mg Tablet
Reason Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class III · Low risk Terminated
FUROSEMIDE Tablets USP
Reason 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 Terminated
FUROSEMIDE Tablets USP
Reason 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 Terminated
UN1002 Air
Reason CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk Terminated
UN1002 Air
Reason CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk Terminated
ClomiPHENE CITRATE Tablets
Reason Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class III · Low risk Terminated
Bravelle 75 IU
Reason Subpotent Drug
Class III · Low risk Terminated
ImproVue Ophthalmic Lubricant Drops
Reason Falied pH specification
Class III · Low risk Terminated
Lamivudine Oral Solution
Reason 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 Terminated
Hydrocortisone and Acetic Acid Otic Solution
Reason 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 Terminated
Rifampin for Injection USP
Reason Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.