Estradiol recall: Foreign Material
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
Why was Estradiol recalled?
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
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 #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
- Product
- Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
- Recalling firm
- B & B Pharmaceuticals, Inc.
- Quantity
- 3,825 grams
- Distribution
- USA Nationwide
- Recall date
- April 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)