Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Prescription Drugs
💊 Drugs • 12,141 recalls
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
Mylan Pharmaceuticals
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Axium Healthcare Pharmacy
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Axium Healthcare Pharmacy
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.
Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Chemical contamination: emission of strong odor after package was opened.
Discoloration; Product may not meet specifications for color description once reconstituted.
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Chemical contamination: emission of strong odor after package was opened.
Chemical contamination: emission of strong odor after package was opened..
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Body Basics
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Chemical contamination: emission of strong odor after package was opened
Chemical contamination: emission of strong odor after package was opened..
Chemical contamination: emission of strong odor after package was opened..
Chemical contamination: emission of strong odor after package was opened.