Sertraline Hydrochloride Tablets Recalled Due to Manufacturing Process Defect
Legacy Pharmaceutical Packaging LLC is recalling 161,664 bottles of Sertraline Hydrochloride 100 mg tablets distributed in California and Arkansas due to inadequate line clearance during manufacturing that may result in product comingling.
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: This is an FDA Class II recall for a manufacturing defect affecting pharmaceutical packaging. The source documents inadequate line clearance that may result in product comingling but does not report illnesses or injuries. Per the rubric, risk-of-harm products without reported injury are classified as High (Score 3).
Plain-English summary
Sertraline Hydrochloride 100 mg tablets are being recalled by Legacy Pharmaceutical Packaging LLC due to manufacturing process deviations. The recall was initiated because of inadequate line clearance during the packaging process, which may result in potential comingling of products.
Approximately 161,664 bottles of Sertraline Hydrochloride 100 mg with Lot #222033 (expiration date 08/31/2024) were distributed to California and Arkansas. The product was distributed by Wal-Mart.
Consumers who possess this medication should contact their healthcare provider or pharmacist for guidance on their specific bottle. Do not discontinue use without medical advice.
The recalled product
- Product
- SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
- Brand
- SERTRALINE HYDROCHLORIDE
- Manufacturer
- Legacy Pharmaceutical Packaging LLC
- Category
- Drug
- Affected units
- 161,664
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 #: 222033
- exp. date 08/31/2024
UPCs (3)
- 0368645522548
- 0368645521541
- 0368645523545
Distribution
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