🍔 Food 💊 Drugs 🏥 Medical Devices
Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01 Class II

Reason: cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office 20220413 Terminated
Distributed: USA nationwide.
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