Wilshire Pharmaceuticals Recalls Meclizine HCl Tablets for Dissolution Failures
Wilshire Pharmaceuticals is recalling 2,112 bottles of Meclizine HCl 12.5 mg tablets found in Florida and Texas because they failed dissolution specifications.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a quality specification failure without reported harm.
Plain-English summary
Wilshire Pharmaceuticals Inc. is recalling 2,112 bottles of Meclizine HCl Tablets, USP, 12.5 mg. The affected product is identified by Lot # 18030318 and an expiration date of 03/2021. The recall was initiated because the tablets failed to meet required dissolution specifications.
The recalled product was distributed in Florida and Texas. Meclizine HCl is a prescription medication. The source text does not report any illnesses or injuries associated with this recall.
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01
- Manufacturer
- Wilshire Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,112
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 #: 18030318
- Exp 03/2021
Distribution
Part of a larger recall action
This product is one of 2 recalled by Wilshire Pharmaceuticals Inc 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Wilshire Pharmaceuticals Inc
See all →- ModerateWilshire Pharmaceuticals Recalls Meclizine HCl Tablets for Dissolution Failures
FDA (Drugs) · 2021-02-24
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