Why it was recalled
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Product description
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), 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
Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021
Where it was sold
USA Nationwide
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-1293-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 19, 2020
- FDA report date
- Jun 17, 2020
- Quantity
- 15,755 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1293-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 85745
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020; 183019, Exp 01/31/2021
- Postal code
- 43217-1188
- Report date
- Jun 17, 2020
- Product type
- Drugs
- Recall number
- D-1293-2020
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 15,755 cartons
- Termination date
- Aug 3, 2022
- Reason for recall
- Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2020