Estrone USP recall: CGMP Deviations
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription…
Why was Estrone USP recalled?
cGMP Deviations; lack of quality assurance.
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: 052915-1, 052915-2, exp 5/5/2017
- Product
- ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription…
- Recalling firm
- American Pharmaceutical Ingredients LLC
- Quantity
- 1g=1 bottle; 5g=4 bottle; 25g=3 bottles
- Distribution
- NY, GA, NV, CA, KY, TX
- Recall date
- June 21, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)