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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 7041–7060 of 17,773 recalls

Class IITerminated

Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRx NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

ImprimisRx NJ

Subpotent Drug

July 17, 2019 · DrugView details →

Class IITerminated

Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA

Macleods Pharma Usa Inc

Failed Dissolution Specifications

July 17, 2019 · DrugView details →

Class IITerminated

Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979

ImprimisRx NJ

Subpotent Drug

July 17, 2019 · DrugView details →

Class IITerminated

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01

Lupin Pharmaceuticals Inc.

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.

July 17, 2019 · DrugView details →

Class IIITerminated

Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01

Lupin Pharmaceuticals Inc.

Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.

July 17, 2019 · DrugView details →

Class IITerminated

Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

July 16, 2019 · DrugView details →

Class IITerminated

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

July 16, 2019 · DrugView details →

Class IITerminated

Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

July 16, 2019 · DrugView details →

Class IITerminated

Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.

Bionpharma Inc.

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

July 16, 2019 · DrugView details →

Class IITerminated

Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

July 16, 2019 · DrugView details →

Class IITerminated

Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

July 16, 2019 · DrugView details →

Class IITerminated

Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Deva Holding AS - Cerkezkoy Subesi

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

July 16, 2019 · DrugView details →

Class IITerminated

LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com

La Fresh Group, Inc.

Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.

July 15, 2019 · DrugView details →

Class IITerminated

DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

July 15, 2019 · DrugView details →

Class IITerminated

CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

July 15, 2019 · DrugView details →

Class IITerminated

CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

July 15, 2019 · DrugView details →

Class IITerminated

Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

July 12, 2019 · DrugView details →

Class IITerminated

Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

July 12, 2019 · DrugView details →

Class IITerminated

Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

July 12, 2019 · DrugView details →

Class IITerminated

Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

Herbal Doctor Remedies

CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.

July 12, 2019 · DrugView details →

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