Pain Aid ESF Bulk Tablets Recall Due to Manufacturing Process Failures
ULTRAtab Laboratories is recalling Pain Aid ESF bulk tablets due to failed stability test results and inadequate laboratory investigations, which represent deviations from manufacturing standards.
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: This is an FDA Class II recall involving manufacturing process deviations. The source does not report any illnesses, injuries, or deaths, and the hazards are manufacturing-related process failures rather than direct product contamination or defects with immediate health impact. The recall is based on process compliance issues rather than confirmed product harm.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling Pain Aid ESF (Acetaminophen USP 250mg, Aspirin USP 250mg, Caffeine 65mg) coated bulk tablets in 100 lb corrugated boxes lined with polyethylene bags. The recall involves 14 bulk lots with various expiration dates ranging from November 2021 through July 2023.
The product is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturing process failed stability testing and the firm conducted inadequate laboratory investigations, which are violations of manufacturing standards for drug products.
The product was distributed to one customer who may have further distributed it downstream. Consumers or businesses who have received this product should stop using it and contact their supplier for instructions on return or disposal.
The recalled product
- Product
- PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Over-the-counter tablets
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 (20)
- Bulk Lots: 18K070
- exp. date Nov-21
- 19A046
- exp. date Jan-22
- 19C073
- exp. date Mar-22
- 19E014
- exp. date May-22
- 19G039
- exp. date Jul-22
- 19K002
- exp. date Nov-22
- 20A013
- exp. date Jan-23
- 20B050
- exp. date Feb-23
- 20C011
- exp. date Mar-23
- 20C049
- 20F071
Distribution
Distribution scope not specified by the agency.
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