54 FDA recalls mention Alpha. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alpha.
Reason Chemical contamination; presence of lead and lithium above specification
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason Lack of Assurance of Sterility
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Reason Subpotent drug
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Reason CGMP Deviations
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Reason Lack of assurance of sterility.
Reason Lack of Assurance of Sterility
Reason Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Reason GMP Deviations
Reason Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Reason Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
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