GLYCOPYRROLATE

Generic: GLYCOPYRROLATE

Accord HealthcareManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
GLYCOPYRROLATEActive Substance
2020-07-08Original Approval

GLYCOPYRROLATE is FDA application ANDA213238, sponsored by ACCORD HLTHCARE. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2023-02-07
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured fo

CGMP Deviations: recalling drug products following an FDA inspection.

Class III2025-12-15
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway

Failed Impurities/Degradation Specifications

Class II2022-12-16
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08

Failed Impurities/Degradation Specifications

Class II2022-12-22
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 384

Failed impurities/degradation specifications: Out of specification for unknown impurities.

Class III2020-02-07
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intrav

Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in

Class III2023-06-06
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-

Labeling: Label Mix-up

Class II2023-02-07
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for:

CGMP Deviations: recalling drug products following an FDA inspection.

Class III2021-01-28
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Heal

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

Class II2022-03-17
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-

Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which cam

Class II2023-02-07
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured fo

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
DYSPNOEA
1,036 reports
2
ASTHMA
835 reports
3
WHEEZING
712 reports
4
COUGH
658 reports
5
PNEUMONIA
570 reports
6
DRUG INEFFECTIVE
432 reports
7
FATIGUE
369 reports
8
OFF LABEL USE
368 reports
9
MALAISE
360 reports
10
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
359 reports