Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel…
Reason GMP Deviations: inadequate manufacturing control processes
Yes — there is an active recall. 60 ongoing FDA recalls mention Lidocaine (365 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lidocaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason GMP Deviations: inadequate manufacturing control processes
Reason GMP Deviations: inadequate manufacturing control processes
Reason Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Reason CGMP Deviations
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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