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Class III: unlikely to cause harmTerminated

Amerisource Health Services Paricalcitol Capsules Recall

Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106…

Amerisource Health Services · Columbus, OH

Risk level
Class III
Reported by FDA
Oct 19, 2016
Recall ID
D-0009-2017
Check your lot numberHow we source this data

Summary

Amerisource Health Services recalled Paricalcitol Capsules starting Sep 30, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0009-2017 on Oct 19, 2016. Reason: Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.

Product description

Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.

Lot numbers, UPCs & expiration codes

Lot 154341, Exp 03/17

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-0009-2017
Classification
Class III
Status
Terminated
Recall initiated
Sep 30, 2016
FDA report date
Oct 19, 2016
Quantity
648 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Amerisource Health Services

Original FDA data

Every field from FDA enforcement report D-0009-2017, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
75335
Address
2550 John Glenn Ave Ste A
Code information
Lot 154341, Exp 03/17
Postal code
43217-1188
Report date
Oct 19, 2016
Product type
Drugs
Recall number
D-0009-2017
Classification
Class III
Recalling firm
Amerisource Health Services
Product quantity
648 cartons
Termination date
Jun 29, 2017
Reason for recall
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
Distribution pattern
Nationwide
Recall initiation date
Sep 30, 2016
Initial firm notification
Letter
Center classification date
Oct 11, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0009-2017, published Oct 19, 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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