Drug Recall: Coated Back Relief Tablet CGMP Deviations
ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text identifies this as an FDA Class II recall for CGMP deviations. The source does not report any illnesses, injuries, or product defect outcomes; the hazard is procedural and precautionary in nature, warranting a Moderate severity score.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling approximately 25,769,495 tablets of Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) in bulk container form (NDC 62959-800-00). The recall was initiated on January 26, 2022, and classified by the FDA as Class II on February 9, 2022.
The recall is due to current good manufacturing practice (CGMP) deviations identified in the manufacturing process. The bulk product was distributed to three distributors, who may have distributed finished product to downstream customers.
Consumers or healthcare providers who have this product in stock should discontinue use and contact ULTRAtab Laboratories, Inc. for instructions on return or disposal. The recall was terminated on January 7, 2025.
The recalled product
- Product
- Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 25,769,495
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)
- Product Codes: M800L Bulk Lots: 18K005
- 18K075
- 18K098
- 18M064
- 19C021
- 19C050
- 19G081
- 19G082
- 19H012
- 19H013
- 19J036
- 19J037
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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