The Recall Desk
ModerateFDA (Drugs)·D-1298-2014·Announced 2014-05-07

P&L Developments Recalls Children's Cold and Cough Liquid for Precipitate

P&L Developments is recalling 1,363,338 bottles of Children's Triacting Night Time Cold & Cough with PE because small amounts of diphenhydramine and mannitol precipitated out of solution.

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 III, which is defined as unlikely to cause adverse health consequences. The hazard is a physical change in the solution (precipitate) with no reported illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

P&L Developments, LLC is recalling 1,363,338 bottles of Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. The product was distributed nationwide in the US under multiple brand names, including Aaron Health KIDS, FAMILY wellness, Good Neighbor Pharmacy, Pedia Care, Quality Choice, Safeway, and Well at Walgreens.

The recall was initiated due to the presence of precipitate, specifically small amounts of diphenhydramine and mannitol that precipitated out of solution. The source text does not report any illnesses or injuries associated with this issue.

Consumers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, consumers should stop using it and contact the recalling firm or the retailer where it was purchased for a refund or replacement.

The recalled product

Product
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) F
Manufacturer
P&L Developments, LLC
Category
Drug — OTC Cold & Cough
Hazard
Affected units
1,363,338

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 (20)

  • Lot # (expiry): Aaron Health A) 73825 (6/14)
  • 74141 (6/14)
  • 74830 (6/14)
  • 74898 (7/14)
  • 75339 (7/14)
  • 75455 (7/14)
  • 78531 (9/14)
  • 79050 (9/14)
  • 79267 (10/14)
  • 80017 (7/14)
  • 80781 (7/14)
  • 81121 (10/14)
  • 82178 (10/14). FAMILY wellness B) 82312 (10/14)
  • 82500 (10/15)
  • 133197 (1/15)
  • 140385 (1/15)
  • 141937 (2/15)
  • 142669 (2/15)
  • 143201 (2/15)
  • 143656 (2/15)

Distribution

Distributed nationwide across the United States.

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