Pharmatech Recalls Sennazon Syrup Due to Potential B. cepacia Contamination
Pharmatech LLC is recalling 1,008 bottles of Sennazon (sennosides) Syrup nationwide due to a potential risk of contamination with B. cepacia bacteria.
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 recall is classified as FDA Class II and is described as a precautionary measure due to a potential risk of contamination, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary actions without reported illness.
Plain-English summary
Pharmatech LLC is recalling 1,008 bottles of Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottles. The product is manufactured for Bayshore Pharmaceuticals and carries the NDC 76518-100-08. The specific lot number is 20391519, with an expiration date of 11/17.
The recall was initiated as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations. These deviations created a potential risk of product contamination with the bacteria B. cepacia. The affected product was distributed nationwide.
Consumers who have this product should stop using it and contact Pharmatech LLC or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
- Manufacturer
- Pharmatech LLC
- Category
- Drug — Liquid Oral Medication
- Hazard
- Affected units
- 1,008
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 #: 20391519
- Exp 11/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Pharmatech LLC 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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