1,055 recalls · Class II, newest first
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Defective Container; leaking around the cap
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Crystallization: Formation of crystals observed in product.
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Failed Dissolution Specifications; 12 month stability time point
Failed Dissolution Specification; at the 6-month stability time point
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.