CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Children's Ibuprofen, Oral Suspension recalled
Central Shared Services is recalling Children's Ibuprofen, Oral Suspension, 200 mg/ cup Berry Flavor, Alcohol Free, Mfg, distributed in Georgia, Kentucky, Tennessee. The recall was initiated on 23 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1062-2014
- FDA event ID
- 66313
- Recalling firm
- Central Shared Services, Nashville, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2013
- FDA classified
- 4 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 23 Aug 2013 | Recall initiated by company | |
| 4 Feb 2014 | Classified by FDA | +165 days |
| 12 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
Where it was distributed
GA, KY, TN
Questions about this recall
Why was it recalled?
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Which lots are affected?
600709, Use by: 04/14; 598148, Use by 04/14; 567904, Use by 01/14; 606466, Use by 05/14
Where was it sold?
GA, KY, TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Children's Ibuprofen recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension USP, 100 mg recalled | Taro Pharmaceuticals U | Particulate Matter | Nationwide |