P & L Developments Recalls Cetirizine Oral Solution Due to Bacterial Contamination
P & L Developments, LLC is recalling 17,664 bottles of Cetirizine 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 significant health hazards, meeting the criteria for a Severe rating.
Plain-English summary
P & L Developments, LLC is voluntarily recalling 17,664 bottles of Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle. The product is distributed by C.D.M.A. Inc. in Novi, MI, and carries the NDC 63868-430-04 and UPC 635515992474.
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 lots are C04866, C09863 (Exp. 10/19), F01267 (Exp. 12/19), F12609 (Exp. 2/20), and F25327 (Exp. 8/20).
The product was distributed nationwide in the U.S. Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the place of purchase or disposed of according to local regulations.
The recalled product
- Product
- Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
- Manufacturer
- P & L Developments, LLC
- Category
- Drug — Antihistamine
- Affected units
- 17,664
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 (9)
- Lot #s: C04866
- C09863
- Exp. 10/19
- F01267
- Exp. 12/19
- F12609
- Exp. 2/20
- F25327
- Exp. 8/20.
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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