Recalls / Class III
Class IIID-0250-2021
Product
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)
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Intramuscular, Intravenous
- NDCs
- 16729-471, 16729-472, 16729-473, 16729-474
- FDA application
- ANDA213238
- Affected lot / code info
- Lot: M2013645 Exp. Aug. 2022
Why it was recalled
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare, Inc.,
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 502 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-01-28
- FDA classified
- 2021-02-08
- Posted by FDA
- 2021-02-17
- Terminated
- 2022-02-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0250-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.