20 FDA recalls mention Labetalol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Labetalol.
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason cGMP deviations: Temperature abuse
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals…
Reason Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date…
Reason Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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 Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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