Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Hydrocortisone and acetic acid otic solution
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk
Acetasol HC
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk
Desoximetasone Gel USP
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Class III · Low risk
Children's Qnasl 40 mcg
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Class III · Low risk
DULOXETINE Delayed-Release Capsules
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Carvediol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets USP
Failed Dissolution Specifications
Class III · Low risk
Methylprednisolone Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Class III · Low risk
Seconal Sodium
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class III · Low risk
Sirolimus Tablets
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Ciprofloxacin OPTH 0.3% SOL
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class III · Low risk
CEFTRIAXONE for Injection USP
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Class III · Low risk
Irbesartan and Hydrochlorothiazide Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Class III · Low risk
Pramipexole Dihydrochloride Extended Release Tablets
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Class III · Low risk
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE…
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Class III · Low risk
Lisinopril Tablets USP
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.