SENNA Syrup unit-dose cups recalled for microbial contamination
Lohxa, LLC is recalling SENNA Syrup (sennosides) 8.8 mg/5 mL unit-dose cups due to microbial contamination of the non-sterile product. The recall affects Lot #AM1115S with expiration date 01/2023, distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is an FDA Class I recall of a drug product with a microbial contamination hazard affecting a non-sterile product. Per the rubric, FDA Class I recalls are never scored below 4. Although no specific illnesses are reported in the source text, the classification and hazard type meet the threshold for Severe.
Plain-English summary
Lohxa, LLC is recalling SENNA Syrup (sennosides) 8.8 mg/5 mL unit-dose cups packaged in 24 cups per carton, manufactured for AvKARE, TN 38478 (NDC 50262-731-24). The recall is due to microbial contamination of the non-sterile product.
The affected product is Lot #AM1115S with expiration date 01/2023. A total of 87,840 unit-dose cups were distributed to one wholesale distributor, who further distributed the product nationwide in the USA.
Consumers who have this product should stop using it. Healthcare providers and patients should contact their healthcare provider if they have already used this product and have any concerns.
The recalled product
- Product
- SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
- Manufacturer
- Lohxa, LLC
- Category
- Drug — Laxative / Oral Syrup
- Affected units
- 87,840
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)
- Lot #: AM1115S
- Exp. Date 01/2023
Distribution
Distributed nationwide across the United States.
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