BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
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Prescription Drugs
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Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Sun Pharmaceutical Industries
Class I - Dangerous
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Class I - Dangerous
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Wellness BioSciences
Class I - Dangerous
Marketed Without an Approved NDA/ANDA
Class I - Dangerous
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
SCA Pharmaceuticals
Class I - Dangerous
Subpotent Drug: Out of specification results for low potency was obtained.
C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
Pharmacy Plus, Inc.
Class I - Dangerous
Lack of assurance of sterility.
Class I - Dangerous
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class I - Dangerous
Out of specification (OOS) for Spectroscopic Identification test by IR.
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.