Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
FDA Drug Recalls
170 recalls · Class III, newest first
Class III · Low risk
Estradiol 12.5 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Estradiol 3 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone 12.5 mg Pellet
Superpotent and Subpotent drugs
Class III · Low risk
Testosterone Cholesterol
Superpotent and Subpotent drugs
Class III · Low risk
PREMARIN (conjugated estrogen tablets, USP)
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
Xanax (Alprazolam)
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
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications
Class III · Low risk
Cytotec (misoprostol)
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class III · Low risk
Lansoprazole Delayed-Release Capsules
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
Varithena (polidocanol injectable foam)
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Class III · Low risk
Vyvanse (lisdexamfetamine dimesylate)
Presence of Foreign Tablets/Capsules
Class III · Low risk
Mozobil (plerixafor injection)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Ramipril Capsules
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class III · Low risk
ZENATANE (isotretinoin capsules USP)
Failed Dissolution Specifications
Class III · Low risk
Selegiline HCL Tablets USP 5mg
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
Lamotrigine Tablets
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class III · Low risk
Amoxicillin For Oral Suspension
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class III · Low risk
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Mozobil (plerixafor injection)
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Class III · Low risk
Mucinex Sinus-Max Day Night
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
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
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).