The Recall Desk
ModerateFDA (Drugs)·D-1062-2014·Announced 2014-02-12

Children's Ibuprofen Recalled for Abnormal Appearance and Discoloration

Central Shared Services dba Parallon is recalling 3,764 cups of Children's Ibuprofen Oral Suspension due to discoloration and failure to meet appearance specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a cosmetic defect (discoloration) and does not report any illnesses, injuries, or serious health risks, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Central Shared Services dba Parallon is recalling 3,764 cups of Children's Ibuprofen, Oral Suspension, 200 mg/10mL cup, Berry Flavor, Alcohol Free. The product was manufactured by Actavis and packaged by Safecor in Columbus, Ohio. The recall was initiated after a complaint was received regarding the abnormal appearance of the suspension.

The recall is due to a Current Good Manufacturing Practice (CGMP) deviation where the product failed the specification for appearance and color, specifically exhibiting discoloration. The affected lots have use-by dates of 04/14, 01/14, and 05/14, with specific code numbers 600709, 598148, 567904, and 606466.

The product was distributed in Georgia, Kentucky, and Tennessee. Consumers should check their inventory for these specific lot numbers and use-by dates. If found, they should stop using the product and contact the recalling firm for instructions on disposal or return.

The recalled product

Product
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
Manufacturer
Central Shared Services dba Parallon
Category
Drug — Pediatric OTC
Hazard
Affected units
3,764

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 600709
  • Use by: 04/14
  • 598148
  • Use by 04/14
  • 567904
  • Use by 01/14
  • 606466
  • Use by 05/14

Distribution

Distributed in 3 states:

Related recalls

Same hazard · discoloration

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