Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Recalls of antidepressants, anti-anxiety and related psychiatric medications.
226 recalls in this category, newest first.
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Reason Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Reason Subpotent Drug
Reason Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4…
Reason Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug…
Reason Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of…
Reason Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of…
Reason Subpotent Drug
Reason Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Dissolution Specifications; 12 month stability time point
Reason Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Reason Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Reason Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Reason Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg…
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