Why it was recalled
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 32809101, Exp 3/2021
Where it was sold
Product was distributed within the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1071-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 30, 2020
- FDA report date
- Apr 8, 2020
- Quantity
- 29,352 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-1071-2020, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85333
- Address
- 1 Ram Ridge Rd
- Code information
- Lot # 32809101, Exp 3/2021
- Postal code
- 10977-6714
- Report date
- Apr 8, 2020
- Product type
- Drugs
- Recall number
- D-1071-2020
- Classification
- Class II
- Recalling firm
- Par Pharmaceutical Inc.
- Product quantity
- 29,352 bottles
- Termination date
- Nov 2, 2021
- Reason for recall
- Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed within the United States.
- Recall initiation date
- Mar 30, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2020