🍔 Food 💊 Drugs 🏥 Medical Devices
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22. Class I

Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Novartis Pharmaceuticals Corp. 20230908 Ongoing
Distributed: Nationwide in the USA
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Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807 Class III

Reason: Incorrect/Undeclared Excipients.

Vi-Jon, LLC 20230905 Terminated
Distributed: The consignee list includes one distributor with seven distribution centers. No product was sold under government contract. No product was sold to any federal, state, or local agency in the school lunch program.
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Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96 Class III

Reason: Subpotent: Out of Specification result observed for low assay

SUN PHARMACEUTICAL INDUSTRIES INC 20230907 Terminated
Distributed: Nationwide wide in the USA
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Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93 Class II

Reason: Failed dissolution specifications - results obtained were below spec average.

Aurobindo Pharma USA Inc. 20230802 Terminated
Distributed: USA nationwide
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BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case). Class II

Reason: Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.

CareFusion 213, LLC 20230825 Completed
Distributed: Distributed nationwide to 100 consignees. Please refer to consignee list.
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octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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