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.
What this means for you
Illness, injury, or structural failure has been reported. 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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