West-ward Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Particulates
West-ward Pharmaceutical Corp. 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 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving physical foreign substances in oral medications that pose a risk of injury.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling 43,478 bottles of Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg. The affected products are packaged in 100-count bottles (NDC 0143-1264-01) and 1,000-count bottles (NDC 0143-1264-10). The recall covers lots 69392A through 69397A (Exp 09/15) and lots 69495A, 69496A, 69497A, 69498A, 69524A, and 69525A (Exp 10/15).
The recall was initiated due to the presence of a foreign substance. Reports identified gray smudges in the tablets as minute stainless steel particulates. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If found, the products should be returned to the pharmacy or point of distribution for a refund or replacement.
The recalled product
- Product
- Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 43,478
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 (14)
- Lot #: 69392A
- 69393A
- 69394A
- 69395A
- 69396A
- 69397A
- Exp 09/15
- 69495A
- 69496A
- 69497A
- 69498A
- 69524A
- 69525A
- Exp 10/15
Distribution
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