FDA Drug recall D-0663-2017
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and…
- FDA Drug
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and… 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-0663-2017 |
| 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
ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732
Reason
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Identifiers
| code_info | a) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 12631…a) 126317/D,126317/F,127288/C, 127296/D, 136212/C, 137155/C,137156/C, 138638/C,138646/B, 138646/E, 138646/I b) 126317/C, 126317/E, 127288/B, 127296/C, 136212/B, 137155/B, 137156/B, 138638/B, 138646/A, 138646/D,138646/H c) 126317/B,127288/A,127296/B, 136212/A, 137155/A, 137156/A,138638/A, 138646/C, 138646/G, 141219/A d) 126317/A, 127296/A, 138646/F |
|---|
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-0663-2017%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.