Caffeine and vitamin dietary supplement tablets recalled for manufacturing practice deviations
ULTRAtab Laboratories recalls Ephrine Plus dietary supplement tablets due to manufacturing practice deviations. The recall involves 4,250,842 tablets distributed to bulk distributors in New York and Florida.
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 recall initiated voluntarily by the manufacturer due to manufacturing practice deviations, with no reported illnesses or injuries. The recall is based on potential risk from process violations rather than confirmed contamination or adverse health events, qualifying it as a voluntary precautionary recall.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling Ephrine Plus Tablet dietary supplement, which contains 200 mg of caffeine and 25 mg of vitamin C per tablet. The recall involves 4,250,842 tablets with product codes M943 and M943L and bulk lots 16K038 and 18B075.
The recall was initiated due to violations of current good manufacturing practices (cGMP). ULTRAtab Laboratories voluntarily initiated the recall on October 6, 2021.
The bulk product was distributed to two wholesale distributors in New York and Florida, who may have repackaged and further distributed the finished product. Consumers who have purchased this product should discontinue use. Individuals with health concerns should consult their healthcare provider.
The recall was terminated on September 1, 2022.
The recalled product
- Product
- Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Food — Dietary Supplement
- Hazard
- manufacturing-deviation
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: M943 M943L Bulk Lots: 16K038
- 18B075
Distribution
Distributed in 2 states:
- FL
- NY
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