Class I - Dangerous
Out of specification (OOS) for Spectroscopic Identification test by IR.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Labeling; Incorrect NDC number on outer carton of product.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class I - Dangerous
CGMP Deviations: Discoloration
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class I - Dangerous
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Teva Pharmaceuticals USA
Class I - Dangerous
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class I - Dangerous
cGMP Deviations
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
Preferred Pharmaceuticals
Class I - Dangerous
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
Preferred Pharmaceuticals
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class I - Dangerous
Sub-potent drug: assay test result below specifications at 9-month timepoint.