The Recall Desk
HighFDA (Drugs)·D-0077-2023·Announced 2022-12-14

Desmopressin Acetate Tablets Recalled by Manufacturer for Subpotency

RemedyRepack Inc. is recalling Desmopressin Acetate Tablets due to subpotency. The affected tablets may not provide the intended therapeutic effect.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall with identified manufacturing defect affecting drug potency. No illnesses or injuries have been reported, but subpotency in a prescription medication poses risk of therapeutic failure and potential patient harm from ineffective treatment.

Plain-English summary

RemedyRepack Inc. is recalling Desmopressin Acetate Tablet, 0.2 mg, in 100-count boxes due to subpotency. The affected product includes NDC 70518-3493-00 with lot numbers B1817019-082222 (expiration 02/24/2023) and B1819127-082322 (expiration 02/26/2023).

The repackaged tablets were found to be subpotent, meaning they may not contain the full intended amount of active pharmaceutical ingredient and may not provide the expected therapeutic effect.

The product was distributed to two customers in Michigan. Patients who received this medication should contact their healthcare provider to discuss their current medication and treatment options. Do not discontinue use without consulting your healthcare provider.

The recalled product

Product
Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
Manufacturer
RemedyRepack Inc.
Hazard
  • sub-potency

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 (4)

  • Lot # B1817019-082222
  • Exp. 02/24/2023
  • B1819127-082322
  • Exp. 02/26/2023

Distribution

Distributed in 1 state:

  • MI