Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Glycopyrrolate Injection Recalled by Accord Healthcare, Inc. Due to Labeling; Label Mix-up; correctly labeled 2 mL vials...

Date: January 28, 2021
Company: Accord Healthcare, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Accord Healthcare, Inc. directly.

Affected Products

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)

Quantity: 502 cartons

Why Was This Recalled?

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Accord Healthcare, Inc.

Accord Healthcare, Inc. has 76 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report