Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg recall — FDA D-426-2013
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Subpotent Drug: The products were below specification for potency at the expiry stability point.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot…
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the…
Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the…
Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an…
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the…
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the…
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the…
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