FDA (Drugs) recall action 92341
The FDA (Drugs) publishes a recall like this one as 52 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 52 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.
Astral SteriTech is recalling 41,500 vials of Ceftriaxone for Injection due to lack of assurance of sterility. The antibiotic was distributed nationwide.
Ceftriaxone for Injection is being recalled due to lack of assurance of sterility. The recall affects 65,950 vials distributed nationwide in the United States.
Xellia Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. Approximately 23,187 bottles were distributed nationwide; patients should consult their healthcare provider.
The FDA is recalling 169,520 vials of Piperacillin and Tazobactam injectable antibiotic due to lack of assurance of sterility. The affected vials were distributed nationwide.
Approximately 936,680 vials of Piperacillin and Tazobactam for Injection are being recalled nationwide due to lack of assurance of sterility. All affected lots remain within their expiration dates.
Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.
Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.
Astral SteriTech is recalling approximately 66,250 vials of Ceftriaxone for Injection due to lack of sterility assurance. The injectable antibiotic poses a potential contamination risk if used.
The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.
Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.
Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.
Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.
Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.
Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.
Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.
FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.
Astral SteriTech recalls 223,590 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assured sterility. Patients and healthcare providers should stop use and consult their provider.
Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.