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Class II: temporary or reversible health riskTerminated

American Health Packaging Desmopressin Acetate Tablets Recall

Desmopressin Acetate Tablets, 0

American Health Packaging · Columbus, OH

Risk level
Class II
Reported by FDA
Feb 26, 2020
Recall ID
D-0849-2020
Check your lot numberHow we source this data

Summary

American Health Packaging recalled Desmopressin Acetate Tablets starting Feb 7, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0849-2020 on Feb 26, 2020. Reason: GMP Deviations: Product bottle may be absent of desiccant. Status: Terminated.

Why it was recalled

GMP Deviations: Product bottle may be absent of desiccant.

Product description

Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11

Lot numbers, UPCs & expiration codes

Lot 180510, exp 3/31/2020; Lot 181912, exp 4/30/2020

Where it was sold

Nationwide USA

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-0849-2020
Classification
Class II
Status
Terminated
Recall initiated
Feb 7, 2020
FDA report date
Feb 26, 2020
Quantity
3,720 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
American Health Packaging

Original FDA data

Every field from FDA enforcement report D-0849-2020, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
84990
Address
2550 John Glenn Ave Ste A
Code information
Lot 180510, exp 3/31/2020; Lot 181912, exp 4/30/2020
Postal code
43217-1188
Report date
Feb 26, 2020
Product type
Drugs
Recall number
D-0849-2020
Classification
Class II
Recalling firm
American Health Packaging
Product quantity
3,720 cartons
Termination date
Aug 4, 2022
Reason for recall
GMP Deviations: Product bottle may be absent of desiccant.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
Distribution pattern
Nationwide USA
Recall initiation date
Feb 7, 2020
Initial firm notification
Letter
Center classification date
Feb 18, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0849-2020, published Feb 26, 2020. 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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