Par Pharmaceutical Recalls Glycopyrrolate Tablets Due to Unknown Impurity
Par Pharmaceutical is recalling 29,352 bottles of Glycopyrrolate Tablets, USP 1 mg, because an unknown impurity was detected.
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 source text explicitly identifies the agency classification as Class II. Per the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when specific impurity failures are involved.
Plain-English summary
Par Pharmaceutical Inc. is recalling 29,352 bottles of Glycopyrrolate Tablets, USP 1 mg, 100-count bottles. The affected product is prescription-only and was distributed within the United States. The specific lot number is 32809101, with an expiration date of 3/2021.
The recall was initiated because an unknown impurity was observed in the product, resulting in a failure of impurities/degradation specifications. The agency has classified this as a Class II recall.
Consumers and healthcare providers should check their inventory for the specific NDC number 49884-0065-01 and lot number 32809101. If the product matches these details, it should be returned to the pharmacy or supplier for a refund.
The recalled product
- Product
- Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01
- Manufacturer
- Par Pharmaceutical Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 29,352
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 # 32809101
- Exp 3/2021
Distribution
Distribution scope not specified by the agency.
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