Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
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Prescription Drugs
💊 Drugs • 12,141 recalls
SLIMFIT X capsules, packaged in a 60-cont bottle
Jersey Shore Supplements
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Class I - Dangerous
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Accord Healthcare
Class I - Dangerous
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class I - Dangerous
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Class I - Dangerous
Superpotent Drug: Product may not meet specifications throughout shelf life.
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Dr. Reddy's Laboratories
Class I - Dangerous
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
Aurobindo Pharma USA
Class I - Dangerous
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class I - Dangerous
Defective Container: Leakage of unit dose cups that may occur at the seal.
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.