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Class III: unlikely to cause harmTerminated

Amerisource Health Services AHP NIFEdipine Capsules Recall

AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01)

Amerisource Health Services · Columbus, OH

Risk level
Class III
Reported by FDA
Nov 30, 2016
Recall ID
D-0144-2017
Check your lot numberHow we source this data

Summary

Amerisource Health Services recalled AHP NIFEdipine Capsules starting Oct 13, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0144-2017 on Nov 30, 2016. Reason: Presence of Foreign Tablets/Capsules. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules

Product description

AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217

Lot numbers, UPCs & expiration codes

Lot #155404 ; Exp 01/18 Lot #161139,163060,164054, 164809; Exp 03/18

Where it was sold

US

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-0144-2017
Classification
Class III
Status
Terminated
Recall initiated
Oct 13, 2016
FDA report date
Nov 30, 2016
Quantity
5283 cartons (100 capsules per carton = 528,300 capsules)
Recall type
Voluntary: Firm initiated
Recalling firm
Amerisource Health Services

Original FDA data

Every field from FDA enforcement report D-0144-2017, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
75470
Address
2550 John Glenn Ave Ste A
Code information
Lot #155404 ; Exp 01/18 Lot #161139,163060,164054, 164809; Exp 03/18
Postal code
43217-1188
Report date
Nov 30, 2016
Product type
Drugs
Recall number
D-0144-2017
Classification
Class III
Recalling firm
Amerisource Health Services
Product quantity
5283 cartons (100 capsules per carton = 528,300 capsules)
Termination date
Sep 28, 2017
Reason for recall
Presence of Foreign Tablets/Capsules
Voluntary / mandated
Voluntary: Firm initiated
Product description
AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
Distribution pattern
US
Recall initiation date
Oct 13, 2016
Initial firm notification
Letter
Center classification date
Nov 18, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0144-2017, published Nov 30, 2016. 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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