Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001…
Reason Lack of Assurance of Sterility
79 FDA recalls mention Ascorbic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ascorbic.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be…
Reason Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Reason Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of…
Reason Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Labeling:Label Mixup; ASCORBIC ACID Tablet, 500 mg may be potentially mislabeled as FEBUXOSTAT, Tablet, 40 mg, NDC 64764091830, Pedigree…
Reason Labeling: Label Mixup: ASCORBIC ACID, CHEW Tablet, 500 mg may have potentially been mislabeled as the following drug: PHENOL, LOZENGE, 29 mg, NDC…
Reason Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: OXcarbazepine, Tablet, 150 mg, NDC…
Reason Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL, Tablet, 100 mg…
Reason Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200…
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
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