Sandoz Recalls Children's Cetirizine Hydrochloride Chewable Tablets Due to Impurities
Sandoz Incorporated is recalling specific lots of Children's Cetirizine Hydrochloride Chewable Tablets because they exceeded impurity specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the source text does not report any illnesses or injuries.
Plain-English summary
Sandoz Incorporated is recalling specific lots of Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count blister packs, and Major Pharmaceuticals' All Day Allergy Children's Cetirizine HCl 5 mg, 5-count blister packs. The recall involves 67,937 cartons of the 30-tablet packs and 24,640 cartons of the 5-tablet packs. The affected products were distributed nationwide.
The recall was initiated because the products exceeded impurity specifications at the 8 and 15-month time points, specifically regarding betacyclodextrin ester 1 and 2. The affected NDC 0781-5283-64 lots are BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437. The affected NDC 0904-5878-33 lot is BW0665.
Consumers should check their medication packaging for these specific NDC numbers and lot codes. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or Sandoz Incorporated for further instructions.
The recalled product
- Product
- CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE)
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — OTC Antihistamine
- Hazard
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 (7)
- NDC 0781-5283-64 lots: BT2862
- BT7986
- BT7994
- BW0652
- CC1961
- and CA3437
- NDC 0904-5878-33 lot BW0665.
Distribution
Distributed nationwide across the United States.
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