FDAFDA · Food and drugs·Recall number D-0666-2017
ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261
Published April 19, 2017 · Recall initiated: April 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medisca, Inc.
- Distributor
- Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
- Lot
- a) 129669/C, 129669/F, 129669/H, 129669/J, 130941/B 130941/D, 130941/F, 136108/B, 139091/B; b) 129669/B, 129669/E, 130941/A, 130941/C, 130941/E,130941/G, 136108/A,
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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