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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 5961–5980 of 17,773 recalls

Class IITerminated

Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Terminated

Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

The Medicine Shoppe Pharmacy

Lack of Processing Control

April 6, 2020 · DrugView details →

Class IITerminated

Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA

Golden State Medical Supply Inc.

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

April 3, 2020 · DrugView details →

Class IITerminated

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

Lupin Pharmaceuticals Inc.

Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.

April 1, 2020 · DrugView details →

Class IITerminated

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3

Noven Therapeutics, LLC

Defective Delivery System: Out of specification for mechanical peel and shear.

March 31, 2020 · DrugView details →

Class IITerminated

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3

Noven Therapeutics, LLC

Defective Delivery System: Out of specification for mechanical peel and shear.

March 31, 2020 · DrugView details →

Class IITerminated

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3

Noven Therapeutics, LLC

Defective Delivery System: Out of specification for mechanical peel and shear.

March 31, 2020 · DrugView details →

Class IITerminated

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01

Par Pharmaceutical Inc.

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

March 30, 2020 · DrugView details →

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