Recalls / Class II
Class IID-0583-2018
Product
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
- Brand name
- Valumeds Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDC
- 68210-0800
- FDA application
- ANDA091239
- Affected lot / code info
- Lot#: HJ6138
Why it was recalled
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Recalling firm
- Firm
- Spirit Pharmaceuticals, LLC
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2004 Orville Dr N Ste 2, N/A, Ronkonkoma, New York 11779-7645
Distribution
- Quantity
- 144 bottles
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2018-01-10
- FDA classified
- 2018-03-09
- Posted by FDA
- 2018-03-14
- Terminated
- 2021-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0583-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.