Lupin Pharmaceuticals Inc.: Drug Recall

Recall Details

Recall Number

D-1081-2023

Classification

Class I

Product Type

Drug

Recalling Firm

Lupin Pharmaceuticals Inc.

Status

Terminated

Date Initiated

06/23/2023

Location

Baltimore, MD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch

Reason for Recall

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Product Description

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA

Distribution Pattern

USA nationwide.

Other Recalls by Lupin Pharmaceuticals Inc.

• Class II: Risk 11/13/2025
  Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
• Class II: Risk 11/05/2025
  Defective container - seal not adhering to bottles
• Class II: Risk 07/02/2025
  Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
• Class II: Risk 06/27/2025
  Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
• Class II: Risk 06/20/2025
  Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

View all recalls by Lupin Pharmaceuticals Inc. →