Class III · Low risk Terminated
PARICALCITOL Capsules
Reason Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
PARICALCITOL Capsules
Reason Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk Terminated
Estradiol 12.5 mg Pellet
Reason Superpotent and Subpotent drugs
Class III · Low risk Terminated
Estradiol 3 mg Pellet
Reason Superpotent and Subpotent drugs
Class III · Low risk Terminated
Testosterone 12.5 mg Pellet
Reason Superpotent and Subpotent drugs
Class III · Low risk Terminated
Testosterone Cholesterol
Reason Superpotent and Subpotent drugs
Class III · Low risk Terminated
Premarin
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Class III · Low risk Terminated
Xanax
Reason Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Class III · Low risk Terminated
mitoXANTRONE Injection USP
Reason Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Cytotec
Reason Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class III · Low risk Terminated
Lansoprazole Delayed-Release Capsules
Reason Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Class III · Low risk Terminated
Varithena
Reason Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Class III · Low risk Terminated
Vyvanse
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
Mozobil
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Zenatane
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Selegiline HCL Tablets USP 5mg
Reason Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class III · Low risk Terminated
Amoxicillin For Oral Suspension
Reason Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class III · Low risk Terminated
Claravis
Reason Failed Impurities/Degradation Specifications.
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).