Drug recall D-0235-2018

Class II Terminated reported Jan 31, 2018

Product

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.

Lots and codes

Lot #: HH6001, HH6002, Exp 04/18

Recall details

Recalling firm
Marksans Pharma Inc., Hauppauge, NY
Quantity
2,853,500 Caplets
Distribution
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
January 9, 2018
Terminated
May 26, 2020

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