Sato Pharmaceutical Recalls Subpotent Wal-Dram 2 Meclizine Hydrochloride Tablets
Sato Pharmaceutical Inc. is voluntarily recalling specific lots of Wal-Dram 2 Quick-Dissolving tablets because they 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 as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a dangerous allergen.
Plain-English summary
Sato Pharmaceutical Inc. is voluntarily recalling specific lots of Wal-Dram 2 Quick-Dissolving (meclizine hydrochloride) 25 mg tablets. The recall was initiated because the affected products are subpotent, meaning they contain less than the labeled amount of the active ingredient. The recall covers 12-count and 18-count boxes distributed nationwide within the United States, Guam, and Saipan.
The affected lots are identified by the following lot numbers and expiration dates: AXWA (Feb 2021), AXAB (May 2021), AXLK (Nov 2021), and AXZP (Jul 2021). The total quantity involved is 112,104 units of the 12-count boxes and 24,696 units of the 18-count boxes. 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 who have these specific lots of Wal-Dram 2 Quick-Dissolving tablets should check their lot numbers and expiration dates against the list above. If the product matches the recalled lots, consumers should stop using it and contact Sato Pharmaceutical Inc. or their healthcare provider for further instructions. The recall was initiated on October 1, 2019, and was terminated on August 18, 2020.
The recalled product
- Product
- WAL-DRAM 2 QUICK-DISSOLVING (MECLIZINE HYDROCHLORIDE)
- Brand
- WAL-DRAM 2 QUICK-DISSOLVING
- Manufacturer
- Sato Pharmaceutical Inc.
- Category
- Drug — OTC Antihistamine
- Hazard
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 (8)
- Lot #: a) AXWA
- Exp. date Feb 2021
- AXAB
- Exp. date May 2021
- AXLK
- Exp. date Nov 2021
- b) AXZP
- Exp. date Jul 2021
UPCs (2)
- 311917183282
- 311917203188
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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