Why it was recalled
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Product description
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
Lot numbers, UPCs & expiration codes
Lot: M2013645 Exp. Aug. 2022
Where it was sold
Nationwide
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-0250-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 28, 2021
- FDA report date
- Feb 17, 2021
- Quantity
- 502 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0250-2021, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 87233
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lot: M2013645 Exp. Aug. 2022
- Postal code
- 27703-8446
- Report date
- Feb 17, 2021
- Product type
- Drugs
- Recall number
- D-0250-2021
- Classification
- Class III
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 502 cartons
- Termination date
- Feb 8, 2022
- Reason for recall
- Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 28, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2021