Estradiol USP 99.5% recall: Sterility Concern
Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01)…
Why was Estradiol USP 99.5% recalled?
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility 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: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009 Exp.: 11/01/2015; A011 Exp.: 11/2/2015; A014 Exp.: 11/8/2015; A016 Exp.: 11/10/2015; A027 Exp.: 11/20/2015; A028 Exp.: 11/21/2015; A030 Exp.: 11/22/2015; A032 Exp.: 11/23/2015; A037 Exp.: 11/24/2015; A039 Exp.: 11/27/2015; A042 Exp.: 11/28/2015; A044 Exp.: 11/29/2015; A050 Exp.: 12/06/2015; A051 Exp.: 12/10/2015; A053 Exp.: 12/12/2015; A062 Exp.: 12/20/2015; A065 Exp.: 12/28/2015
- Product
- Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01)…
- Recalling firm
- Qualgen
- Quantity
- 4,221 vials
- Distribution
- Nationwide
- Recall date
- December 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)