Why it was recalled
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 8170-9004, Exp 01/2020
Where it was sold
Nationwide in the USA.
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-0850-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 28, 2020
- FDA report date
- Feb 26, 2020
- Quantity
- 6929 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NCS Healthcare of Kentucky Inc
Original FDA data
Every field from FDA enforcement report D-0850-2020, exactly as published.
Show all FDA fields
- City
- Glasgow
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 84992
- Address
- 120 Carroll Knicely Dr
- Code information
- Lot #: 8170-9004, Exp 01/2020
- Postal code
- 42141-7224
- Report date
- Feb 26, 2020
- Product type
- Drugs
- Recall number
- D-0850-2020
- Classification
- Class II
- Recalling firm
- NCS Healthcare of Kentucky Inc
- Product quantity
- 6929 blister cards
- Termination date
- Feb 19, 2021
- Reason for recall
- Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jan 28, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 18, 2020