Home / Recalls / Medisca, Inc. / D-0664-2017

D-0664-2017 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

ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891

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) 124880/D,124880/O, 130940/J, 135312/E b) 124880/C 124880/F 124880/I 124880/N 130940/D 130940/I 135312/D 135312/I 136546/D 139489/B c) 124880/B, 124880/H, 124880/M, 130940/C, 130940/H, 135312/C, 135312/H, 136546/C d) 124880/A ,130940/B, 130940/G, 135312/B, 135312/G, 136546/B, 139489/A e) 124880/G, 124880/J, 124880/L,130940/A, 130940/F, 135312/A, 135312/F, 136546/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-0666-2017 Class II — ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (April 3, 2017)
  • D-0665-2017 Class II — ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 (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)