Back Relief II Drug Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.
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 FDA classified this as a Class II recall. The source identifies no reported illnesses, hospitalizations, or injuries; the hazard is a manufacturing-practice deviation rather than a confirmed product defect or safety failure. Class II recalls are typically scored 2 unless accompanied by hospitalization reports or injury evidence.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) bulk containers. The product has NDC 62959-740-00 and affected product codes are M740LA with bulk lots 19C022 and 19C023. The recall involves approximately 1,477,641 tablets.
The firm initiated this recall due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall. The bulk product was distributed to 3 distributors, who may have distributed finished product to other entities.
Consumers should not use this product. Anyone affected by use of the recalled product should consult their healthcare provider. For questions, contact the recalling firm at the address provided in official recall documentation.
The recalled product
- Product
- Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Pain reliever
- Hazard
- Affected units
- 1,477,641
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 (2)
- Product Codes: M740LA Bulk Lots: 19C022
- 19C023
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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