Recalls / Class II
Class IID-0235-2018
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.
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 25000-114, 25000-117
- FDA application
- ANDA091239
- Affected lot / code info
- Lot #: HH6001, HH6002, Exp 04/18
Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recalling firm
- Firm
- Marksans Pharma Inc.
- Manufacturer
- MARKSANS PHARMA LIMITED
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Suite # 401, 4th Floor, Room No. 430, 150 Motor Parkway, Hauppauge, New York 11788
Distribution
- Quantity
- 2,853,500 Caplets
- Distribution pattern
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2018-01-09
- FDA classified
- 2018-01-24
- Posted by FDA
- 2018-01-31
- Terminated
- 2020-05-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0235-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.