Why it was recalled
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Product description
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Lot numbers, UPCs & expiration codes
Lot#: HJ6138
Where it was sold
NY
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-0583-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- 144 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spirit Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0583-2018, exactly as published.
Show all FDA fields
- City
- Ronkonkoma
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 79361
- Address
- 2004 Orville Dr N Ste 2
- Code information
- Lot#: HJ6138
- Postal code
- 11779-7645
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0583-2018
- Classification
- Class II
- Recalling firm
- Spirit Pharmaceuticals, LLC
- Product quantity
- 144 bottles
- Termination date
- Jan 20, 2021
- Reason for recall
- CGMP deviations: Ibuprofen is being recalled in response to previous recall
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
- Distribution pattern
- NY
- Recall initiation date
- Jan 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2018