Class III · Low risk
Glipizide XL
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Glucotrol XL
Failed Dissolution Specification; 8 hr stability timepoint
Class III · Low risk
Acyclovir Oral Suspension
Failed Stability Specification; product viscosity and or pH are below specification.
Class III · Low risk
Ciclopirox Shampoo 1%
Subpotent. drug
Class III · Low risk
Potassium Chloride
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
Class III · Low risk
G & W Fluocinolone Acetonide Cream USP 0.025%
Failed Content Uniformity Specifications; at the 18 month time point.
Class III · Low risk
Hydroxychloroquine Sulfate Tablets
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Class III · Low risk
Ketoconazole Shampoo
Subpotent
Class III · Low risk
Acanya (Clindamycin Phosphate and Benzoyl Peroxide)
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.
Class III · Low risk
Endometrin
Discoloration; due to prolonged heat exposure.
Class III · Low risk
Venlafaxine
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Class III · Low risk
Loratadine 24 HR-OTC
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Timolol Maleate Sterile Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Ofloxacin Ophthalmic Solution
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Class III · Low risk
Derma-Smoothe/FS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Giltuss Antitussive Expectorant and Nasal Decongestant
Subpotent; phenylephrine HCl
Class III · Low risk
Loratadine
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Class III · Low risk
SPIRIVA HandiHaler
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.