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