🍔 Food 💊 Drugs 🏥 Medical Devices
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15. 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 Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15. 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 Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11. 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 Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15. Class II

Reason: Lack of Assurance of Sterility

Optikem International, Inc. 20240229 Ongoing
Distributed: Product distributed Nationwide in the USA
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Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 Class II

Reason: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

Thea Pharma, Inc. 20240305 Terminated
Distributed: Product was distributed nationwide within the United States
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Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10 Class II

Reason: cGMP Deviations: Products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20240207 Terminated
Distributed: Product was distributed to three direct accounts in NM, AZ and UT.
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Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01 Class II

Reason: cGMP Deviations: Products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20240207 Terminated
Distributed: Product was distributed to three direct accounts in NM, AZ and UT.
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Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10 Class II

Reason: cGMP Deviations: Products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20240207 Terminated
Distributed: Product was distributed to three direct accounts in NM, AZ and UT.
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Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20 Class II

Reason: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.

B. Braun Medical Inc 20240306 Terminated
Distributed: Nationwide in the USA
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Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01. Class II

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

SUN PHARMACEUTICAL INDUSTRIES INC 20240304 Ongoing
Distributed: Nationwide
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