Acetaminophen 325 mg Tablets Recalled Due to Manufacturing Deviations
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.
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: This is a Class II drug recall initiated voluntarily by the manufacturer for CGMP deviations. No reported illnesses, injuries, or deaths are stated in the source text. The hazard is manufacturing-process related rather than a confirmed contamination or high-risk pathogen, placing it at Moderate severity.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Coated APAP 325mg (Acetaminophen 325 mg) tablets in bulk container format. The recall involves product with NDC 62959-202-00 and affects bulk lots 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, and 19H074, with approximately 16,429,211 tablets involved.
The recall was initiated due to CGMP Deviations in the manufacturing process. The bulk product was distributed to three distributors, who may have distributed finished products made from this material to further customers.
Consumers or healthcare providers who have this product should contact their supplier or distributor for instructions on return or disposal. This is a Class II recall, meaning the defect could cause adverse health consequences or death, though no specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Tablet / Bulk Container
- Affected units
- 16,429,211
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)
- Product Codes: L202L Bulk Lots: 18K013
- 18K014
- 18K015
- 19A040
- 18M076
- 19A041
- 19H072
- 19H073
- 19H074
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 33 recalled by ULTRAtab Laboratories, 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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