Class I - Dangerous
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,
Denver Solutions, LLC
Class I - Dangerous
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class I - Dangerous
cGMP deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class I - Dangerous
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class I - Dangerous
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class I - Dangerous
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
The Harvard Drug Group LLC
Class I - Dangerous
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Somerset Therapeutics Private Limited
Class I - Dangerous
Lack of Assurance of Sterility: Media fill with bacterial contamination
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
CGMP Deviations