The Recall Desk
SevereFDA (Drugs)·D-1409-2019·Announced 2019-06-26

P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination

P & L Developments is recalling 124,512 bottles of Up & Up Children's Cetirizine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant contamination risks like bacterial pathogens.

Plain-English summary

P & L Developments, LLC is recalling 124,512 bottles of Up & Up Children's allergy relief Cetirizine Oral Solution 1 mg/mL, Grape Flavor, 4 FL. oz. (118 mL). The product was distributed nationwide in the U.S. by Target Corporation. The recall was initiated after the firm was notified by its supplier of a voluntary recall due to potential contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).

The affected product is identified by NDC 11673-178-04 and UPC 359726178044. Specific lot numbers and expiration dates are listed in the recall documentation, including lots A98495, C03882, A49664, C06541, C05532, F00527, F00528, F07279, F07842, and F10237.

Consumers should stop using the product and check their lot numbers against the list provided by the recalling firm. The FDA classifies this as a Class II recall, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044.
Manufacturer
P & L Developments, LLC
Category
Drug — Antihistamine
Hazard
Affected units
124,512

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 (15)

  • Lot #s: A98495
  • C03882
  • A49664
  • Exp. 5/19
  • C06541
  • Exp. 6/19
  • C05532
  • F00527
  • Exp. 10/19
  • F00528
  • F07279
  • Exp. 12/19
  • F07842
  • F10237
  • Exp. 2/20.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by P & L Developments, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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