Why it was recalled
Lack of Sterility Assurance.
Product description
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
Lot numbers, UPCs & expiration codes
Lot #: 9783, BUD: 7/27/2017; 9801, BUD: 7/29/2017; 9807, BUD: 7/30/2017; 9847, BUD: 8/4/2017; 9954, BUD: 8/20/2017; 10022, BUD: 9/1/2017; 10052, BUD: 9/6/2017; 10063, BUD: 9/7/2017; 10086, BUD: 9/9/2017; 10108, BUD: 9/13/2017; 10156, BUD: 9/20/2017; 10180, BUD: 9/22/2017; 10245, BUD: 9/29/2017; 10264, BUD: 9/30/2017; 10322, BUD: 10/8/2017; 10339, BUD: 10/13/2017; 10368, BUD: 10/18/2017; 10406, BUD: 10/25/2017; 10419, BUD: 10/26/2017; 10435, BUD: 10/28/2017; 10455, BUD: 11/1/2017; 10489, BUD: 11/5/2017; 10497, BUD: 11/6/2017; 10516, BUD: 11/9/2017; 10527, BUD: 11/10/2017; 10577, BUD: 11/19/2017
Where it was sold
Nationwide within the US
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-1065-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 14, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 75840 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cantrell Drug Company
Original FDA data
Every field from FDA enforcement report D-1065-2017, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 77780
- Address
- 7321 Cantrell Rd
- Code information
- Lot #: 9783, BUD: 7/27/2017; 9801, BUD: 7/29/2017; 9807, BUD: 7/30/2017; 9847, BUD: 8/4/2017; 9954, BUD: 8/20/2017; 10022, BUD: 9/1/2017; 10052, BUD: 9/6/2017; 10063, BUD: 9/7/2017; 10086, BUD: 9/9/2017; 10108, BUD: 9/13/2017; 10156, BUD: 9/20/2017; 10180, BUD: 9/22/2017; 10245, BUD: 9/29/2017; 10264, BUD: 9/30/2017; 10322, BUD: 10/8/2017; 10339, BUD: 10/13/2017; 10368, BUD: 10/18/2017; 10406, BUD: 10/25/2017; 10419, BUD: 10/26/2017; 10435, BUD: 10/28/2017; 10455, BUD: 11/1/2017; 10489, BUD: 11/5/2017; 10497, BUD: 11/6/2017; 10516, BUD: 11/9/2017; 10527, BUD: 11/10/2017; 10577, BUD: 11/19/2017
- Postal code
- 72207-4144
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1065-2017
- Classification
- Class II
- Recalling firm
- Cantrell Drug Company
- Product quantity
- 75840 syringes
- Termination date
- Sep 16, 2020
- Reason for recall
- Lack of Sterility Assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222; NDC 52533-028-15
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Jul 14, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2017