27 FDA recalls mention Tobramycin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tobramycin.
Reason Failed Stability Specification: Water determination was found not complying with specification.
Reason Failed Impurities/Degradation Specifications
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Lack of sterility assurance
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason CGMP Deviations:
Reason CGMP Deviations:
Reason cGMP deviations: Temperature abuse
Reason Lack of Processing Controls
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Reason Lack of sterility assurance.
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 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 Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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