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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Accord Healthcare, Inc.: Glycopyrrolate Injection Recalled for Packaging and Labeling Mix-up

Agency Publication Date: February 8, 2021
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Summary

Accord Healthcare, Inc. is recalling 502 cartons of Glycopyrrolate Injection, USP (0.4 mg/2 mL). The recall was initiated because 2 mL vials were incorrectly packaged into blister strips labeled for 1 mL vials, even though the individual vials inside are correctly labeled. Consumers should contact their healthcare provider or pharmacist regarding this medication, as the labeling error could lead to confusion about the volume of the dose being administered.

Risk

The packaging mix-up involves 2 mL vials placed in 1 mL blister strips, which may cause a healthcare provider to misinterpret the dosage or volume of the medication. This poses a risk of dosing errors during administration.

What You Should Do

  1. Check your medication packaging for Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) in 25 x 2 mL Single Dose Vial cartons.
  2. Identify if your product is affected by looking for Lot number M2013645 with an expiration date of August 2022 (Aug. 2022).
  3. Verify the NDC numbers on the packaging: the carton NDC is 16729-472-08 and the individual vial NDC is 16729-472-30.
  4. Compare the label on the individual 2 mL vial to the label on the blister strip; the recall applies if a 2 mL vial is found inside a blister strip labeled for 1 mL.
  5. Contact your healthcare provider or pharmacist immediately for guidance if you have this medication.
  6. Return any unused product to your pharmacy for a refund and contact Accord Healthcare, Inc. for further instructions.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials
Model:
NDC 16729-472-08
Vial NDC 16729-472-30
Lot Numbers:
M2013645 (Exp. Aug. 2022)
Date Ranges: Expiration August 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87233
Status: Resolved
Manufacturer: Accord Healthcare, Inc.
Manufactured In: India, United States
Units Affected: 502 cartons
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.