Glycopyrrolate Injection Recalled for Failed Impurities and Degradation Specifications
Meitheal Pharmaceuticals is recalling Glycopyrrolate Injection, USP 4mg per 20mL in 20mL multi-dose vials due to failed impurities and degradation specifications. The recall affects specific lots distributed nationwide in the USA and India.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall, which typically corresponds to a severity score of 1 or 2. The hazard is related to failed chemical specifications (impurities and degradation) with no reported illnesses or injuries in the source text, making this a precautionary recall. The score of 2 reflects the pharmaceutical nature and potential for patient impact if specifications were significantly compromised.
Plain-English summary
Meitheal Pharmaceuticals Inc is recalling Glycopyrrolate Injection, USP 4mg per 20mL supplied in 20mL multi-dose vials (NDC 71288-408-21) because the product failed to meet impurities and degradation specifications. This is a prescription-only medication manufactured for Meitheal Pharmaceuticals in Chicago, Illinois.
The recall involves approximately 1,160 ten-pack cartons with the following lot numbers and expiration dates: Lot #G0010120 (Exp. December 2021), Lot #G0080520 (Exp. April 2022), and Lots #G0090221 and #G0100221 (Exp. January 2023). These lots were distributed nationwide within the USA and to India.
Healthcare providers and patients who have received or are using Glycopyrrolate Injection from the affected lots should consult with their pharmacist or physician regarding their use of the product. The FDA has classified this as a Class III recall.
The recalled product
- Product
- Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
- Manufacturer
- Meitheal Pharmaceuticals Inc
- Category
- Drug — Injectable Pharmaceutical
- Affected units
- 1,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: G0010120
- Exp. Date December 2021
- G0080520
- Exp. Date April 2022
- G0090221
- G0100221
- Exp. Date January 2023
Distribution
Distributed nationwide across the United States.
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