PYRIDOSTIGMINE BROMIDE Recall D-0018-2023
Description: Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
PYRIDOSTIGMINE BROMIDE Recall D-0018-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0018-2023 |
Event ID | 90943 |
Brand | PYRIDOSTIGMINE BROMIDE |
Generic Name | PYRIDOSTIGMINE BROMIDE |
Manufacturer | PYRIDOSTIGMINE BROMIDE |
Active Substance | PYRIDOSTIGMINE BROMIDE |
Drug Route | ORAL |
Distribution | USA Nationwide |
Quantity | 1980 cups |
Recall Reason | cGMP Deviations: Out of specification for assay of one of the preservative ingredients. |
Drug Classification | Class II |
Drug Code Info | 20221102 |
Product NDC | 66689-406 |
Recall Initiation Date | 20220930 |
Report Date | 20221102 |
Classification Date | 20221021 |
Address | 7265 Ulmerton Rd Largo, FL 33771-4809 United States |
Recalling Firm | VistaPharm, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | KVI301NA53 |
Drug Application Number | ANDA211694 |
Structured Product Labeling (SPL ID) | be11a5b5-9644-4e47-b464-9b51a00a46a9 |
Structured Product Labeling (SPL Set ID) | 9ab2ece0-7c0d-4045-a9f1-447aa97d623e |
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