Why it was recalled
Subpotent
Product description
Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01
Lot numbers, UPCs & expiration codes
The following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11
Where it was sold
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-323-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 2, 2013
- FDA report date
- Dec 11, 2013
- Quantity
- 1536 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-323-2014, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 66451
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- The following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11
- Postal code
- 43217-1188
- Report date
- Dec 11, 2013
- Product type
- Drugs
- Recall number
- D-323-2014
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 1536 cartons
- Termination date
- Jun 26, 2015
- Reason for recall
- Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 2, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2013