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Prescription Drugs

💊 Drugs • 11,927 recalls

SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10

New England Life Care, Inc.

Class I - Dangerous

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Jul 10, 2023 Prescription Drugs Nationwide View Details →

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Jul 5, 2023 Prescription Drugs Nationwide View Details →

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

SterRx

Class I - Dangerous

Lack of Assurance of Sterility

Jul 7, 2023 Prescription Drugs Nationwide View Details →

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

SterRx

Class I - Dangerous

Lack of Assurance of Sterility

Jul 7, 2023 Prescription Drugs Nationwide View Details →

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

New England Life Care, Inc.

Class I - Dangerous

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Jul 10, 2023 Prescription Drugs Nationwide View Details →

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Jul 5, 2023 Prescription Drugs Nationwide View Details →

Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Jul 10, 2023 Prescription Drugs Nationwide View Details →

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03

Lupin Pharmaceuticals

Class I - Dangerous

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Jun 27, 2023 Prescription Drugs View Details →

allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.

Accord Healthcare

Class I - Dangerous

Presence of Particulate Matter: Particulate matter identified as fiber.

Jul 3, 2023 Prescription Drugs Nationwide View Details →

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

Cipla USA

Class I - Dangerous

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Jun 27, 2023 Prescription Drugs Nationwide View Details →

Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,

Vivus

Class I - Dangerous

Failed Stability Specifications

Jun 23, 2023 Prescription Drugs Nationwide View Details →

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.

L. Perrigo Company

Class I - Dangerous

Failed Impurities/Degradation Specifications

Feb 9, 2023 Prescription Drugs Nationwide View Details →

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.

Accord Healthcare

Class I - Dangerous

Presence of Particulate Matter: Particulate matter identified as fiber.

Jul 3, 2023 Prescription Drugs Nationwide View Details →

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