FDAFDA · Food and drugs·Recall number D-0664-2017
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
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) 124880/D,124880/O, 130940/J, 135312/E b) 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B c) 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C d) 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A e) 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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