GSMS Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Particulates
GSMS Inc. is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they contain minute stainless steel particulates.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (foreign substance in medication) where injury has not yet been reported, aligning with the 'High' severity criteria.
Plain-English summary
GSMS Inc. is recalling specific lots of Lisinopril and Hydrochlorothiazide Tablets, USP, 20 mg/25 mg. The recall involves 100-count and 1,000-count bottles distributed nationwide. The affected product is prescription-only.
The recall was initiated after the manufacturer identified gray smudges in the tablets. These smudges were determined to be minute stainless steel particulates. The source text does not report any illnesses or injuries associated with this contamination.
Consumers with these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. The affected NDCs are 60429-046-01 and 60429-046-10. Specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA
- Manufacturer
- Gsms
- Category
- Drug — Prescription Medication
- Affected units
- 6,158
Distribution
Distributed nationwide across the United States.
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