Recalls / Class II

Class IID-0665-2017

Product

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 (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869

Affected lot / code info

a) 137169/F b) 129670/G, 129670/K, 130942/G, 130942/L, 131429/G, 131430/G, 137169/E c) 129670/F,129670/J, 130942/F, 130942/K 131429/F, 131430/F, 137169/D, d) 129670/E, 129670/I,130942/E, 130942/J,131429/E, 131430/E, 137169/C e) 129670/D, 129670/H, 130942/D, 130942/I, 131429/D, 131430/D, 131430/H, 137169/B f) 129670/C, 130942/C, 130942/H, 131429/C, 131430/C, 137169/A, 137169/F g) 129670/B, 130942/B, 131429/B, 131430/B h) 129670/A, 130942/A ,131429/A, 131430/A

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-0665-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.