Class III · Low risk Terminated
Claravis
Reason Failed Impurities/Degradation Specifications.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Mozobil
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets
Reason Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Class III · Low risk Terminated
Mucinex Sinus-Max Day Night
Reason Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Class III · Low risk Terminated
Hydrocortisone and acetic acid otic solution
Reason 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 Terminated
Acetasol HC
Reason 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 Terminated
Desoximetasone Gel USP
Reason Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Class III · Low risk Terminated
Children's Qnasl 40 mcg
Reason Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class III · Low risk Terminated
5% Lidocaine HCL and 7.5% Dextrose Injection
Reason Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Class III · Low risk Terminated
DULOXETINE Delayed-Release Capsules
Reason 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 Terminated
Carvediol Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Carvediol Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Carvediol Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Carvediol Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
buPROPion Hydrochloride Extended Release Tablets USP
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Methylprednisolone Tablets
Reason 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 Terminated
Seconal Sodium
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Class III · Low risk Terminated
Cyproheptadine Hydrochloride Syrup
Reason Subpotency: product assayed and found OOS for cyproheptadine
Class III · Low risk Terminated
Sirolimus Tablets
Reason Failed impurities/degradation: out of specification result for impurity secorapamycin.
Class III · Low risk Terminated
Urea
Reason Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk Terminated
Ciprofloxacin OPTH 0.3% SOL
Reason Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Class III · Low risk Terminated
CEFTRIAXONE for Injection USP
Reason CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class III · Low risk Terminated
mitoXANTRONE Injection USP
Reason Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Class III · Low risk Terminated
Irbesartan and Hydrochlorothiazide Tablets
Reason 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.