Meclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
Jubilant Cadista Pharmaceuticals recalls Meclizine Hydrochloride Tablets with incorrect labeling. Bottles labeled as PredniSONE contain Meclizine, risking medication errors.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification establishes a minimum severity of Severe (4). No reported illnesses or deaths are documented in the source, preventing a higher classification to Critical. The labeling error presents a documented risk but without evidence of actual patient harm.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Meclizine Hydrochloride Tablets USP, 12.5 mg due to a labeling error. Cases labeled as containing Meclizine Hydrochloride Tablets include bottles that are labeled as PredniSONE Tablets, even though the actual tablets are Meclizine Hydrochloride.
The recalled product consists of 12,174 bottles (Lot #22P0036, expiration 12/2024) distributed in Arkansas, Florida, North Carolina, South Carolina, and Ohio.
This labeling error could result in patients or healthcare providers misidentifying the product and potentially administering the wrong medication.
The recalled product
- Product
- MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE)
- Brand
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug
- Affected units
- 12,174
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 # 22P0036
- Exp 12/2024
UPCs (2)
- 0359746121068
- 0359746122065
Distribution
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