Cystex Tablet Recall Due to CGMP Manufacturing Deviations
ULTRAtab Laboratories is voluntarily recalling Cystex Tablets (Sodium Salicylate 162.5 mg, Methenamine 162 mg) in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The bulk product was distributed to 3 distributors.
What this means for you
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 without any reported illnesses or injuries. CGMP deviations indicate a manufacturing control issue rather than a known patient harm, making this a precautionary or deficiency-based recall appropriate for a Moderate severity rating.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, NY, is voluntarily recalling Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) in bulk containers. The recall affects approximately 37,464,418 tablets and involves product code M945 with the following bulk lot numbers: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, and 19H098.
The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations identified in the manufacturing process. The bulk product was distributed to 3 distributors who may have distributed finished product to subsequent customers.
The firm notified distributors by letter on January 26, 2022. The recall was classified as FDA Class II on February 9, 2022, and was terminated on January 7, 2025. Consumers who have received this product should contact their supplier or distributor for further instructions regarding the recalled product.
The recalled product
- Product
- Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Urinary tract health
- Hazard
- cgmp-deviation
- manufacturing-control
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 (13)
- Product Codes: M945 Bulk Lots: 18J072
- 18K030
- 18L123
- 19A043
- 19A093
- 19B062
- 19C079
- 19C080
- 19D041
- 19E035
- 19E087
- 19G084
- 19H098
Distribution
Distribution scope not specified by the agency.
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