Estriol 0.1% recall: Labeling Error
Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Why was Estriol 0.1% recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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?
Lot: 07182017@45 BUD: 1/14/2018
- Product
- Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Recalling firm
- KRS Global Biotechnology, Inc
- Quantity
- 300 jars
- Distribution
- Nationwide in the USA, Bermuda, and New Zealand
- Recall date
- January 17, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)