🍔 Food 💊 Drugs 🏥 Medical Devices
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10 Class II

Reason: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Fresenius Medical Care Holdings, Inc. 20221011 Ongoing
Distributed: Nationwide in the USA
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NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com Class III

Reason: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

LNK International, Inc. 20221011 Terminated
Distributed: Nationwide
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Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10. Class II

Reason: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

AuroMedics Pharma LLC 20220926 Completed
Distributed: Nationwide in the USA
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Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30 Class II

Reason: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Golden State Medical Supply Inc. 20221006 Terminated
Distributed: USA nationwide
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Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA. Class II

Reason: Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Golden State Medical Supply Inc. 20221006 Terminated
Distributed: USA nationwide
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Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7 Class II

Reason: Out of specification for related substances (impurities).

Ingenus Pharmaceuticals Llc 20220930 Completed
Distributed: Nationwide within the United States
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Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8 Class II

Reason: Marketed Without An Approved NDA/ANDA; Unapproved new drug

Justified Laboratories 20220909 Terminated
Distributed: United States including Puerto Rico and Canada
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Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1 Class II

Reason: Marketed Without An Approved NDA/ANDA; Unapproved new drug

Justified Laboratories 20220909 Terminated
Distributed: United States including Puerto Rico and Canada
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Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10 Class III

Reason: Presence of Particulate Matter: Piece of metal found in a vial

AuroMedics Pharma LLC 20220926 Ongoing
Distributed: Distributed Nationwide in the USA
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Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. Class II

Reason: Lack of Assurance of Sterility: environmental monitoring failure.

CIPLA 20220929 Terminated
Distributed: Product was distributed nationwide to distributors/wholesalers who may have further distributed the product.
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