🍔 Food 💊 Drugs 🏥 Medical Devices
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. Class II

Reason: Lack of Assurance of Sterility

Northern VA Compounders PLLC 20221230 Terminated
Distributed: Nationwide in the USA
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QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. Class II

Reason: Lack of Assurance of Sterility

Northern VA Compounders PLLC 20221230 Terminated
Distributed: Nationwide in the USA
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Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. Class II

Reason: Lack of Assurance of Sterility

Northern VA Compounders PLLC 20221230 Terminated
Distributed: Nationwide in the USA
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Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05 Class II

Reason: cGMP deviation: discontinue of stability support for product.

Direct Rx 20221102 Terminated
Distributed: FL
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Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06 Class II

Reason: Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Lupin Pharmaceuticals Inc. 20221212 Terminated
Distributed: Distributed Nationwide in the USA
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Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05 Class II

Reason: Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC 20230106 Terminated
Distributed: Nationwide in the USA.
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Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00. Class II

Reason: Failed Impurities/Degradation specifications

RemedyRepack Inc. 20221220 Terminated
Distributed: Product was distributed to one account in PA.
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Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1 Class II

Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Pine Pharmaceuticals, LLC 20221222 Terminated
Distributed: Nationwide to medical facilities.
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Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA, Class II

Reason: Lack of assurance of sterility: Bags have the potential to leak.

Pfizer Inc. 20221229 Completed
Distributed: Nationwide in the USA.
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Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06 Class III

Reason: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

Jubilant Cadista Pharmaceuticals, Inc. 20221227 Terminated
Distributed: Nationwide in the USA.
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