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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 4701–4720 of 17,755 recalls

Class IITerminated

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IIOngoing

Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023

Pfizer Inc.

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

August 13, 2021 · DrugView details →

Class IITerminated

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

SigmaPharm Laboratories LLC

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

Class IITerminated

ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

August 13, 2021 · DrugView details →

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