113 FDA recalls mention Bicarbonate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bicarbonate.
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical…
Reason Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical…
Reason Lack of Assurance of Sterility.
Reason Lack of Sterility Assurance.
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Reason Lack of Assurance of Sterility
Reason Subpotent Drug
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Reason Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic…
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 LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Reason LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Reason Labeling: Label Mixup; SODIUM BICARBONATE Tablet, 650 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001…
Reason Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC…
Reason Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15…
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