24 FDA recalls mention Docusate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Docusate.
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Reason CGMP Deviations
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Reason cGMP Deviations: Products may have microbial contamination.
Reason cGMP Deviations: Products may have microbial contamination.
Reason Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Reason Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Reason Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Reason Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Reason Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: SACCHAROMYCES BOULARDII…
Reason Labeling: Label Mixup: DOCUSATE SODIUM, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PIOGLITAZONE, Tablet, 15…
Reason Labeling: Label Mixup: DOCUSATE CALCIUM, Capsule, 240 mg may have potentially been mislabeled as one of the following drugs: diphenhydrAMINE HCl…
Reason Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101…
Reason Labeling:Label Mixup; DOCUSATE SODIUM Capsule, 100 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701…
Reason Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5…
Reason Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
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