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Prescription Drugs

💊 Drugs • 11,927 recalls

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

Slate Run Pharmaceuticals

Class I - Dangerous

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Mar 7, 2025 Prescription Drugs Nationwide View Details →

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Golden State Medical Supply

Class I - Dangerous

Failed Dissolution Specifications

Mar 5, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

Rising Pharma Holding

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Mar 5, 2025 Prescription Drugs Nationwide View Details →

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

Chattem

Class I - Dangerous

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

Mar 4, 2025 Prescription Drugs Nationwide View Details →

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

Kowa Pharmaceuticals America

Class I - Dangerous

Presence of foreign tablets/capsules

Feb 24, 2025 Prescription Drugs View Details →

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

ICU Medical

Class I - Dangerous

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Feb 13, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Feb 28, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Feb 28, 2025 Prescription Drugs Nationwide View Details →

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.

Feb 10, 2025 Prescription Drugs Nationwide View Details →

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.

Central Admixture Pharmacy Services

Class I - Dangerous

Presence of Particulate Matter

Feb 20, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Feb 28, 2025 Prescription Drugs Nationwide View Details →

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

ICU Medical

Class I - Dangerous

Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

Feb 13, 2025 Prescription Drugs Nationwide View Details →