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Class II: temporary or reversible health riskTerminated

RemedyRepack Desmopressin Acetate Tablet Recall

Desmopressin Acetate Tablet, 0

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
Dec 14, 2022
Recall ID
D-0077-2023
Check your lot numberHow we source this data

Summary

RemedyRepack recalled Desmopressin Acetate Tablet starting Dec 5, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0077-2023 on Dec 14, 2022. Reason: Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. Status: Terminated.

Why it was recalled

Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.

Product description

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Product was distributed to two different customers in MI.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0077-2023
Classification
Class II
Status
Terminated
Recall initiated
Dec 5, 2022
FDA report date
Dec 14, 2022
Quantity
9 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0077-2023, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
91263
Address
625 Kolter Dr Ste 4
Code information
Lot # B1817019-082222, Exp. 02/24/2023; B1819127-082322, Exp. 02/26/2023
Postal code
15701-3571
Report date
Dec 14, 2022
Product type
Drugs
Recall number
D-0077-2023
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
9 boxes
Termination date
Feb 3, 2023
Reason for recall
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Product was distributed to two different customers in MI.
Recall initiation date
Dec 5, 2022
Initial firm notification
Letter
Center classification date
Dec 7, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0077-2023, published Dec 14, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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