NCS Healthcare Recalls Glycopyrrolate Tablets Due to Impurity Failure
NCS Healthcare of Kentucky Inc is recalling 6,929 blister cards of Glycopyrrolate Tablets, USP, 1 mg, due to high out-of-specification results for an unknown impurity.
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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of an unknown impurity that failed specifications.
Plain-English summary
NCS Healthcare of Kentucky Inc is recalling 6,929 blister cards of Glycopyrrolate Tablets, USP, 1 mg, 30-count unit dose blister cards. The product is identified by NDC 0615-8170-39, Lot # 8170-9004, and an expiration date of 01/2020. The recall was initiated because the product failed impurities/degradation specifications, specifically showing high out-of-specification results for an individual unknown impurity.
The affected product was distributed nationwide in the USA. It is labeled "FOR INSTITUTIONAL USE ONLY" and "Rx Only," and was packaged by Vangard in Glasgow, KY. The recall is classified as Class II by the FDA.
Institutional customers and healthcare providers should stop using the affected lot and contact NCS Healthcare of Kentucky Inc for further instructions on returning or disposing of the product. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
- Manufacturer
- NCS Healthcare of Kentucky Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,929
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 #: 8170-9004
- Exp 01/2020
Distribution
Distributed nationwide across the United States.
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