FDAFDA · Food and drugs·Recall number D-0235-2018
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.
Published January 31, 2018 · Recall initiated: January 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IBUPROFEN
- Manufacturer
- Marksans Pharma Inc.
- Distributor
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
- UPC
- 0325000114022
- Lot
- Lot #: HH6001, HH6002, Exp 04/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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