Why it was recalled
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Product description
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
Lot numbers, UPCs & expiration codes
Lot 172569, Exp 7/31/2019
Where it was sold
Nationwide in the 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-1582-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 1, 2018
- FDA report date
- Aug 7, 2019
- Quantity
- 6,579 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1582-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 83466
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 172569, Exp 7/31/2019
- Postal code
- 43217-1188
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1582-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 6,579 cartons
- Termination date
- Sep 30, 2020
- Reason for recall
- Failed Dissolution Specifications: Out of specification result for the dissolution test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 1, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2019