367 FDA recalls mention Amino. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amino.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP deviation: product outside labeled storage temperature requirements.
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Reason Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Reason Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product…
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Reason Lack of assurance of sterility.
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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