Home / Recalls / Medisca, Inc. / D-0665-2017

D-0665-2017 Class II Terminated

Recalled by Medisca, Inc. — Plattsburgh, NY

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 (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

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) 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

Other recalls by Medisca, Inc.

  • D-0386-2025 Class II — Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779 (March 31, 2025)
  • D-0570-2024 Class II — Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p (June 26, 2024)
  • D-0622-2020 Class II — Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packe (November 25, 2019)
  • D-1174-2017 Class II — Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, (September 14, 2017)
  • D-0664-2017 Class II — ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891- (April 3, 2017)
  • D-0666-2017 Class II — ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (April 3, 2017)
  • D-0663-2017 Class II — ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams ( (April 3, 2017)
  • D-0674-2016 Class I — CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or (February 14, 2014)
  • D-1263-2014 Class I — Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use (October 21, 2013)