Why it was recalled
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Product description
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
Lot numbers, UPCs & expiration codes
600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14
Where it was sold
GA, KY, TN
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-1062-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 3764 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Central Shared Services dba Parallon
Original FDA data
Every field from FDA enforcement report D-1062-2014, exactly as published.
Show all FDA fields
- City
- Nashville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 66313
- Address
- 245B Great Circle Road
- Code information
- 600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14
- Postal code
- 37228
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1062-2014
- Classification
- Class II
- Recalling firm
- Central Shared Services dba Parallon
- Product quantity
- 3764 cups
- Termination date
- Feb 4, 2014
- Reason for recall
- CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
- Distribution pattern
- GA, KY, TN
- Recall initiation date
- Aug 23, 2013
- Initial firm notification
- Center classification date
- Feb 4, 2014