Sato Pharmaceutical Recalls Subpotent Motion Sickness Strips Nationwide
Sato Pharmaceutical Inc. is recalling 39,504 units of Motion Sickness Strips because the medication may contain less than the labeled amount of meclizine hydrochloride.
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 recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Sato Pharmaceutical Inc. is voluntarily recalling 39,504 units of Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box. The recall was initiated because the product is subpotent, meaning it may contain less than the labeled amount of the active ingredient.
The affected product is distributed nationwide within the United States, Guam, and Saipan. The specific lots involved are AXTK, AXAK, AXZK, AXNK, AXBK, AXLK, AXPK, and AXCK, all with an expiration date of November 2021. The product is identified by NDC 69842-288-01 and UPC 5042849946.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should check their medication for the listed lot numbers and expiration date. If they have the affected product, they should stop using it and contact Sato Pharmaceutical Inc. or their healthcare provider for further instructions.
The recalled product
- Product
- Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
- Manufacturer
- Sato Pharmaceutical Inc.
- Hazard
- Affected units
- 39,504
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 #: AXTK
- AXAK
- AXZK
- AXNK
- AXBK
- AXLK
- AXPK
- AXCK
- Exp. Date Nov 2021
Distribution
Part of a larger recall action
This product is one of 4 recalled by Sato Pharmaceutical 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.
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