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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 4821–4840 of 17,755 recalls

Class IITerminated

PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

Class IITerminated

PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.

Professional Disposables International, Inc

SubPotent: Out of Specification

July 23, 2021 · DrugView details →

Class IIOngoing

Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

HIS ENTERPRISE INC

Marketed without ANDA/NDA approval

July 20, 2021 · DrugView details →

Class IITerminated

Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.

Teligent Pharma, Inc.

Correct Labeled Product Mispack

July 19, 2021 · DrugView details →

Class IITerminated

Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.

Dr. Reddy's Laboratories, Inc.

Failed Tablet/Capsule Specification: Some tablets are shaved

July 19, 2021 · DrugView details →

Class IITerminated

Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.

Teligent Pharma, Inc.

Correct Labeled Product Mispack

July 19, 2021 · DrugView details →

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

Alpha-Tek LLC

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

July 16, 2021 · DrugView details →

Class IITerminated

Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01

API Solutions Inc.

cGMP Deviations

July 15, 2021 · DrugView details →

Class IITerminated

Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York

API Solutions Inc.

cGMP Deviations

July 15, 2021 · DrugView details →

Class IIOngoing

Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed by JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11033 0

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skillman, NJ 08858,

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ, 08858,

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

Class IIOngoing

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5

Johnson & Johnson Consumer, Inc.

cGMP Deviations

July 14, 2021 · DrugView details →

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