Class III · Low risk Terminated
Calcitriol Oral Solution
Reason Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Equate ClearLAX
Reason Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
TESTOSTERONE 200 mg PELLET
Reason Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk Terminated
ESTRADIOL 20mg PELLET
Reason Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk Terminated
Maxzide-25
Reason Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Resuspension problems: Out of specification for appearance and resuspendability.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Tablets
Reason Labeling: Missing Label
Class III · Low risk Terminated
Zoma Shampoo
Reason Subpotent
Class III · Low risk Terminated
T Shampoo For Hair and Body
Reason Subpotent
Class III · Low risk Terminated
Lidocaine Patch 5%
Reason Failed Stability Specifications
Class III · Low risk Terminated
Riomet
Reason Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk Terminated
Diltiazem CD
Reason Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk Terminated
Aptensio XR
Reason Failed Dissolution Specification: Low dissolution outside of specifications
Class III · Low risk Terminated
OraVerse
Reason Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Class III · Low risk Terminated
Calendula Cream
Reason Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
Class III · Low risk Terminated
Ferrous Sulfate 325 MG tablet
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP
Reason cGMP deviations
Class III · Low risk Terminated
Cystaran
Reason Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Tablets
Reason Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).