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Recall Observatory FDA recall evidence

Drug 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

D-1244-2020

April 14, 2020

Class II

Product summary

Firm
B & B Pharmaceuticals, Inc.
Event
Event 85440
Status
Terminated
Classification
Class II
Quantity
3,825 grams
Official record key
drug-enforcement:D-1244-2020

Official wording

Reason: cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.

Code information: Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363

Distribution pattern: USA Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign material
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations