Recalls / Class II

Class IID-0663-2017

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

Affected lot / 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) 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

Why it was recalled

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Recalling firm

Firm

Medisca, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

661 State Route 3 Unit C, N/A, Plattsburgh, New York 12901-6531

Distribution

Quantity

N/A

Distribution pattern

Nationwide, Australia, Bahamas, Italy, Singapore, Thailand, United Kingdom

Timeline

Recall initiated

2017-04-03

FDA classified

2017-04-12

Posted by FDA

2017-04-19

Terminated

2019-06-18

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0663-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.