Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Nephron Sterile Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
B. Braun Medical
Class I - Dangerous
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
B. Braun Medical
Class I - Dangerous
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
RISING PHARMACEUTICALS
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Subpotent Drug