Yes — there is an active recall. 34 ongoing FDA recalls mention Amino (367 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amino. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Reason Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid…
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 CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations
Reason Labeling: Not elsewhere classified - count on the label was incorrect.
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance.
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Reason Presence of Particulate Matter: identified as dried skin.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Reason Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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