Desmopressin Acetate Tablets recalled for manufacturing process deviations
Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: Voluntary firm-initiated recall for manufacturing process deviations with no reported illnesses or injuries. Classified as precautionary manufacturer action per FDA Class II recall criteria.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA, has voluntarily recalled 36 bottles of Desmopressin Acetate Tablets, 0.2 mg (100-count bottles), due to Current Good Manufacturing Practice (CGMP) deviations. The recalled product was manufactured by Glenmark Pharmaceuticals Ltd. in Goa, India, for Northstar Rx LLC in Memphis, Tennessee. The affected lot is #20020121, with an expiration date of January 2024.
The firm identified manufacturing process deviations that prompted this voluntary recall. Desmopressin acetate is a prescription medication used to treat certain conditions. No illnesses or injuries have been reported in connection with this recall.
The affected product was distributed to one sole distributor in Texas. Consumers and healthcare providers who have this medication should contact their pharmacist or physician for guidance. The recall was initiated on June 29, 2022, and was terminated on June 23, 2023.
The recalled product
- Product
- Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- Affected units
- 36
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 (2)
- Lot #: 20020121
- Exp 01/2024
Distribution
Distributed in 1 state:
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