🍔 Food 💊 Drugs 🏥 Medical Devices
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30. Class II

Reason: Failed Stability Specifications: Out of specification for blend uniformity.

Micro Labs Limited 20240209 Terminated
Distributed: Puerto Rico, TN, RI
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Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12 Class II

Reason: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Global Corporation 20240216 Ongoing
Distributed: Nationwide within the United States
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Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44 Class II

Reason: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Global Corporation 20240216 Ongoing
Distributed: Nationwide within the United States
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Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01. Class II

Reason: Failed Stability Specification: Water determination was found not complying with specification.

Eugia US LLC 20240222 Terminated
Distributed: Nationwide
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hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150 Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15. Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15. Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15. Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15. Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15. Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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