Sato Pharmaceutical Recalls Subpotent Zentrip Meclizine Hydrochloride Strips
Sato Pharmaceutical Inc. is voluntarily recalling Zentrip (meclizine Hydrochloride) 25 mg strips because the medication is subpotent. The recall covers 21,864 units distributed nationwide.
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 Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box. The recall was initiated because the drug is subpotent, meaning it contains less than the labeled amount of the active ingredient. The affected product is distributed by Sato Pharmaceutical Inc. located in Torrance, California, and carries NDC 49873-803-01 and UPC 4987301603.
The recall affects 21,864 units of the medication. The specific lots involved are TXWW and TXTW with an expiration date of December 2019; AXPS, AXLS, AXBS, and AXNS with an expiration date of October 2021; and AXZL, AXAL, AXTL, and AXWL with an expiration date of June 2021. The product was distributed nationwide within the United States, Guam, and Saipan.
This recall was classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was initiated by the firm and was terminated on August 18, 2020. Consumers should check their medication for the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603
- Manufacturer
- Sato Pharmaceutical Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 21,864
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 (12)
- Lot #: TXWW
- TXTW
- Exp. date Dec 2019
- AXPS
- AXLS
- AXBS AXNS
- Exp. date Oct 2021
- AXZL
- AXAL
- AXTL
- AXWL
- Exp. date Jun 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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