Diluent for Reconstitution Each ML contains: 1.5% recall: CGMP Deviations
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia…
Why was Diluent for Reconstitution Each ML contains: 1.5% recalled?
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: D41012 BUD 4/12/2022, D41212 BUD: 4/12/2022, D47026 BUD: 4/26/2022, E41017 BUD: 5/17/2022, E41018 BUD: 5/18/2022, E47004 BUD: 5/4/2022, E47024 BUD: 5/24/2022, E47026 BUD: 5/26/2022, E48005 BUD: 5/5/2022, G47014 BUD: 7/14/2022, H48816 BUD: 8/16/2022
- Product
- Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia…
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Quantity
- 45,935 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)