Normed Fem Tablet Recalled Due to CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors who may have distributed finished product.
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 drug recall involving manufacturing practice deviations without reported illnesses or injuries. Per the severity rubric, Class II recalls without hospitalization reports and no reported harm are classified as Moderate.
Plain-English summary
ULTRAtab Laboratories, Inc. is voluntarily recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, NDC 62959-701-00, distributed from their facility in Highland, NY. The recall affects 452,038 tablets with Product Code M701L and Bulk Lot 19G077.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. CGMP deviations refer to failures to meet federal standards for drug manufacturing quality and safety.
The bulk product was distributed to 3 distributors who may have distributed finished product to other manufacturers or distributors. Consumers who have this product should stop using it and contact their healthcare provider or pharmacist with questions.
This recall was initiated on January 26, 2022, classified as FDA Class II, and was voluntarily undertaken by the firm. The recall was terminated on January 7, 2025.
The recalled product
- Product
- Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Affected units
- 452,038
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 (1)
- Product Codes: M701L Bulk Lots: 19G077
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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