5 FDA recalls mention Theophylline. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Theophylline.
Reason Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the…
Reason OOS results reported for the Dissolution (by UV) test.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with…
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…
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