FDA Drug recall 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…
- FDA Drug
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of 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… by Medisca, citing cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0664-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-03 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Medisca |
| Distribution | US |
Product
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
Reason
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Identifiers
| code_info | 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…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Medisca
- Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Platts…
FDA Drug · Class II · 2025-04-30 · Medisca - Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 3877…
FDA Drug · Class II · 2024-07-10 · Medisca - Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
FDA Drug · Class II · 2019-12-25 · Medisca - Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (N…
FDA Drug · Class II · 2017-09-27 · Medisca - ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g…
FDA Drug · Class II · 2017-04-19 · Medisca
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0664-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.