Meclizine HCl Tablets 25 mg Recalled for Incorrect Instructions
Rising Pharmaceuticals is recalling Meclizine HCl Tablets 25 mg (Lot # CB21024, expiring 2/2023) due to incorrect labeling instructions on the packaging.
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 2/5 (Moderate).
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: This is an FDA Class II recall involving a labeling defect (incorrect instructions). The source text does not indicate any reported illnesses, injuries, or hospitalizations, and labeling errors of this type are typically classified as Moderate per the severity rubric.
Plain-English summary
Rising Pharmaceuticals is recalling Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottles (NDC 16571-752-01) due to incorrect instructions on the product labeling. The affected lot is CB21024 with an expiration date of 2/2023, distributed by Rising Pharma Holdings, Inc. in East Brunswick, NJ and manufactured by Aurex Laboratories LLC in East Windsor, NJ. A total of 1,344 bottles were distributed.
Consumers who have this product should consult the correct prescribing information or contact their healthcare provider or pharmacist for proper usage instructions. Those with questions can contact Rising Pharmaceuticals at the phone number or address provided on the product packaging.
The recalled product
- Product
- Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
- Manufacturer
- RISING PHARMACEUTICALS
- Affected units
- 1,344
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 (2)
- Lot # CB21024
- Exp 2/2023
Distribution
Distribution scope not specified by the agency.
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