P & L Developments Recalls Cetirizine HCL Oral Solution Due to Contamination
P & L Developments, LLC is recalling 202,068 bottles of Cetirizine HCL Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential contamination with Burkholderia cepacia and Ralstonia pickettii, which are high-risk pathogens associated with serious infections, particularly in immunocompromised individuals.
Plain-English summary
P & L Developments, LLC is voluntarily recalling 202,068 bottles of Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle. The product is distributed by Dolgencorp, LLC and was sold nationwide in the U.S.
The recall was initiated after the firm was notified by its supplier of potential contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The affected lot numbers are C00138, A48440, C02434, C04186, C07864, F13277, C08962, F13778, C11746, F05899, F13777, F09356, F10784, F13595, F22355, and F23239, with expiration dates ranging from May 2019 to August 2020.
Consumers should check their inventory for these specific lot numbers and expiration dates. If they have the recalled product, they should stop using it and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
- Manufacturer
- P & L Developments, LLC
- Category
- Drug — Oral Solution
- Affected units
- 202,068
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 #s: C00138
- A48440
- Exp. 5/19
- C02434
- C04186
- Exp. 6/19
- C07864
- Exp. 7/19
- F13277
- C08962
- F13778
- Exp. 10/19
- C11746
- F05899
- F13777
- Exp. 12/19
- F09356
- F10784
- F13595
- 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.
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