D-0666-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 19, 2017
- Initiation Date
- April 3, 2017
- Termination Date
- June 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Distribution Pattern
Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom
Code Information
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,