🍔 Food 💊 Drugs 🏥 Medical Devices
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20231002 Terminated
Distributed: Nationwide within the United States
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Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20231002 Terminated
Distributed: Nationwide within the United States
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Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20231002 Terminated
Distributed: Nationwide within the United States
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Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20231002 Terminated
Distributed: Nationwide within the United States
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Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20231002 Terminated
Distributed: Nationwide within the United States
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Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. Class II

Reason: Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC 20231002 Terminated
Distributed: Nationwide within the United States
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Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01. Class I

Reason: Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

KVK-Tech, Inc. 20230920 Terminated
Distributed: Nationwide in the USA and PR
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Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01 Class II

Reason: CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Baxter Healthcare Corporation 20230824 Terminated
Distributed: Nationwide in the USA
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Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16 Class I

Reason: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

VistaPharm LLC 20231018 Terminated
Distributed: USA Nationwide
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TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628 Class I

Reason: Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

Church & Dwight Inc 20230908 Ongoing
Distributed: Nationwide in the US
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