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This recall involves prescription drugs Aprepitant 125 mg capsules sold in cartons containing one blister card of 6 capsules and 5 gram tubes of Lidocaine and Prilocaine cream sold in cartons containing 5 tubes and packed with or without 12 dressings. The Aprepitant capsules are in a non-child resistant blister card packaged in a carton that has the name "Sandoz," the name of the medication, dosage, NDC number, lot number, and expiration date on the carton and on the blister cards. The warnings "This unit-dose packaging is not child-resistant" and "For institutional use only" are listed on the carton. The Lidocaine and Prilocaine cream is packaged in a 5 gram tube with a continuous thread white closure. The name "fougera®," the name of the medication, dosage and NDC number are printed on the carton and tube and the expiration date and lot number are printed on the carton and stamped on the crimp of the tube. The warning "FOR HOSPITAL USE ONLY" is printed on the carton and the tube. Product Description NDC Number Lot Number Expiration Date Aprepitant Capsules 125 mg 0781-2323-68 Carton of 1 Blister Pack of 6 capsules 0781-2323-06 Blister Pack LK3209 LC6454 04/2024 12/2023 Lidocaine and Prilocaine 2.5%/2.5% Cream 5 gram Tubes 0168-0357-56 Carton of 5 tubes and 12 dressings 0168-0357-55 Carton of 5 tubes 0168-0357-05 Tube LA2782 LA2784 LV0667 LX5350 MA1640 MB3205 LA2785 LR9041 MB3209 03/2023 03/2023 02/2024 03/2024 03/2024 04/2024 03/2023 11/2023 04/2024
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Failed Impurities/Degradation Specifications
The recall involves Samnyte Tattoo Numbing Cream sold in 60ml and contains Lidocaine 5% with Vitamin E. The product was sold in a white tube with a flip-top closure. The drug facts label is on the back.
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
CGMP Deviations: