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Class II: temporary or reversible health riskTerminated

American Health Packaging Valacyclovir HCl Tablets Recall

Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged…

American Health Packaging · Columbus, OH

Risk level
Class II
Reported by FDA
Dec 11, 2013
Recall ID
D-323-2014
Check your lot numberHow we source this data

Summary

American Health Packaging recalled Valacyclovir HCl Tablets starting Aug 2, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-323-2014 on Dec 11, 2013. Reason: Subpotent. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-323-2014, published Dec 11, 2013. 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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