Major Senna Syrup Recalled for Microbial Contamination
The Harvard Drug Group is recalling Major Senna Syrup due to microbial contamination, including yeast and potential B. cepacia.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential B. cepacia contamination, which is a high-risk pathogen associated with significant health risks, meeting the criteria for a Severe rating.
Plain-English summary
The Harvard Drug Group is recalling 26,891 bottles of Major Senna Syrup Natural Vegetable Laxative. The product is distributed by Major Pharmaceuticals and is available in 8 fl. oz. (237 mL) plastic bottles. The recall covers Item # 263923, all lots.
The recall was initiated because of microbial contamination in the non-sterile product. Specifically, the presence of yeast and potential B. cepacia contamination was identified. The FDA has classified this recall as Class II.
The product was distributed nationwide in the USA. Consumers should stop using the product and contact the recalling firm for instructions on how to return it or obtain a refund.
The recalled product
- Product
- Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Laxative
- Affected units
- 26,891
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)
- Item # 263923
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by The Harvard Drug Group 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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