Drug 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
D-0663-2017
Product summary
- Firm
- Medisca, Inc.
- Event
- Event 76873
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0663-2017
Official wording
Reason: cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Code information: 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
Distribution pattern: Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Derived failure modes
-
Manufacturing or process control
cGMP Deviations