44 FDA recalls mention Bupropion. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupropion.
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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 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 Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Reason Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL)…
Reason Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Reason Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981…
Reason Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801…
Reason Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Reason Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Reason Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Reason Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Reason Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
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