FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

American Family Pharmacy Assured Aspirin Enteric Safety Coated Tablets Recall

Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever…

American Family Pharmacy, LLC · Indianapolis, IN

Risk level
Class II
Reported by FDA
Oct 29, 2014
Recall ID
D-0040-2015
Check your lot numberHow we source this data

Summary

American Family Pharmacy recalled Assured Aspirin Enteric Safety Coated Tablets starting Sep 15, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0040-2015 on Oct 29, 2014. Reason: Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution. Status: Terminated.

Why it was recalled

Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.

Product description

Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.

Lot numbers, UPCs & expiration codes

Lot#12084; Exp. 05/16

Where it was sold

VA, WA, and CA.

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-0040-2015
Classification
Class II
Status
Terminated
Recall initiated
Sep 15, 2014
FDA report date
Oct 29, 2014
Quantity
4,207,200 tablets
Recall type
Voluntary: Firm initiated
Recalling firm
American Family Pharmacy, LLC

Original FDA data

Every field from FDA enforcement report D-0040-2015, exactly as published.

Show all FDA fields
City
Indianapolis
State
IN
Status
Terminated
Country
United States
Event ID
69248
Address
3250 N Post Rd Suite 285
Code information
Lot#12084; Exp. 05/16
Postal code
46226-6536
Report date
Oct 29, 2014
Product type
Drugs
Recall number
D-0040-2015
Classification
Class II
Recalling firm
American Family Pharmacy, LLC
Product quantity
4,207,200 tablets
Termination date
Sep 25, 2015
Reason for recall
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
Distribution pattern
VA, WA, and CA.
Recall initiation date
Sep 15, 2014
Initial firm notification
E-Mail
Center classification date
Oct 21, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0040-2015, published Oct 29, 2014. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls