Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Product description
Ibuprofen Tablets, USP 400 mg, 6 x 3500 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 25000-121-29.
Lot numbers, UPCs & expiration codes
Lot #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18
Where it was sold
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0238-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 9, 2018
- FDA report date
- Jan 31, 2018
- Quantity
- 21,584,100 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Marksans Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0238-2018, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78822
- Address
- Suite # 401, 4th Floor
- Address (line 2)
- Room No. 430, 150 Motor Parkway
- Code information
- Lot #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18
- Postal code
- 11788
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0238-2018
- Classification
- Class II
- Recalling firm
- Marksans Pharma Inc.
- Product quantity
- 21,584,100 tablets
- Termination date
- May 26, 2020
- Reason for recall
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen Tablets, USP 400 mg, 6 x 3500 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 25000-121-29.
- Distribution pattern
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
- Recall initiation date
- Jan 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2018