Reported Feb 17, 2021 · Terminated
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord…
Accord Healthcare, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only
- Manufactured forAccord Healthcare, Inc. Durham, NC 27703, USA
- Manufactured byIntas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
- Lot codes and dates
- LotM2013645 Exp. Aug. 2022
- Amount recalled
- 502 cartons
Where it was sold
- Nationwide
Why it was recalled
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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