🍔 Food 💊 Drugs 🏥 Medical Devices
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01 Class III

Reason: Out of specification for assay

Imprimis NJOF, LLC 20240410 Ongoing
Distributed: Nationwide within the United States
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Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. Class II

Reason: Failed Dissolution Specifications

Amneal Pharmaceuticals of New York, LLC 20240325 Completed
Distributed: US Nationwide.
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Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08 Class II

Reason: Subpotent Drug

Imprimis NJOF, LLC 20240410 Ongoing
Distributed: U.S. Nationwide
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minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30. Class II

Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

EPI Health, LLC 20240423 Terminated
Distributed: US Nationwide
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minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30. Class II

Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

EPI Health, LLC 20240423 Terminated
Distributed: US Nationwide
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Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90 Class II

Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

EPI Health, LLC 20240423 Terminated
Distributed: US Nationwide
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Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01. Class II

Reason: Failed Dissolution Specifications

Glenmark Pharmaceuticals Inc., USA 20240417 Ongoing
Distributed: Nationwide in the USA.
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Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53 Class II

Reason: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Cipla USA, Inc. 20240326 Terminated
Distributed: USA nationwide.
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ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card. Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.

FA Online Inc 20240212 Terminated
Distributed: USA Nationwide. The product was sold via Amazon Market Place.
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Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 Class III

Reason: Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. 20240409 Ongoing
Distributed: USA nationwide.
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