Home / Recalls / Marksans Pharma Inc. / D-0235-2018

D-0235-2018 Class II Terminated

Recalled by Marksans Pharma Inc. — Hauppauge, NY

Recall Details

Product Type
Drugs
Report Date
January 31, 2018
Initiation Date
January 9, 2018
Termination Date
May 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,853,500 Caplets

Product Description

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.

Reason for Recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Distribution Pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

Code Information

Lot #: HH6001, HH6002, Exp 04/18

Other recalls by Marksans Pharma Inc.

  • D-0236-2018 Class II — Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag sh (January 9, 2018)
  • D-0237-2018 Class II — Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag sh (January 9, 2018)
  • D-0239-2018 Class II — Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag sh (January 9, 2018)
  • D-0240-2018 Class II — Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag sh (January 9, 2018)
  • D-0238-2018 Class II — Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag sh (January 9, 2018)