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 800 mg, 6 x 1900 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 25000-123-27.
Lot numbers, UPCs & expiration codes
Lot #: Lot #: HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, HM6080, HM6081, HM6082, HM6083, HM6084, HM6085, HM6086, HM6087, HM6088, HM6089, HM6090, HM6091, HM6092, HM6093, HM6094, HM6095, HM6096, Exp 02/18; HM6097, HM6098, HM6099, Exp 03/18; HM6100, HM6101, HM6102, HM6103, HM6104, HM6105, HM6106, HM6107, HM6108, HM6109, HM6110, HM6111, HM6112, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, HM6119, HM6120, HM6121, HM6122, HM6123, HM6124, HM6125, HM6126, HM6127, HM6128, HM6129, HM6130, HM6131, HM6132, Exp 08/18; HM6133, HM6134, HM6135, HM6136, HM6137, HM6128, HM6139; 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-0240-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 9, 2018
- FDA report date
- Jan 31, 2018
- Quantity
- 52,549,000 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Marksans Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0240-2018, 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 #: Lot #: HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, HM6080, HM6081, HM6082, HM6083, HM6084, HM6085, HM6086, HM6087, HM6088, HM6089, HM6090, HM6091, HM6092, HM6093, HM6094, HM6095, HM6096, Exp 02/18; HM6097, HM6098, HM6099, Exp 03/18; HM6100, HM6101, HM6102, HM6103, HM6104, HM6105, HM6106, HM6107, HM6108, HM6109, HM6110, HM6111, HM6112, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, HM6119, HM6120, HM6121, HM6122, HM6123, HM6124, HM6125, HM6126, HM6127, HM6128, HM6129, HM6130, HM6131, HM6132, Exp 08/18; HM6133, HM6134, HM6135, HM6136, HM6137, HM6128, HM6139; Exp 09/18
- Postal code
- 11788
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0240-2018
- Classification
- Class II
- Recalling firm
- Marksans Pharma Inc.
- Product quantity
- 52,549,000 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 800 mg, 6 x 1900 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 25000-123-27.
- 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