Amerisource Health Services CycloSPORINE Capsules Recall

Why it was recalled

Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities

Product description

CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25

Lot numbers, UPCs & expiration codes

Lot 154527, exp 4/30/2017

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-0490-2017
Classification: Class II
Status: Terminated
Recall initiated: Feb 8, 2017
FDA report date: Mar 8, 2017
Quantity: 454 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: Amerisource Health Services

Original FDA data

Every field from FDA enforcement report D-0490-2017, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 76484
Address: 2550 John Glenn Ave Ste A
Code information: Lot 154527, exp 4/30/2017
Postal code: 43217-1188
Report date: Mar 8, 2017
Product type: Drugs
Recall number: D-0490-2017
Classification: Class II
Recalling firm: Amerisource Health Services
Product quantity: 454 cartons
Termination date: Oct 17, 2017
Reason for recall: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Voluntary / mandated: Voluntary: Firm initiated
Product description: CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Distribution pattern: Nationwide
Recall initiation date: Feb 8, 2017
Initial firm notification: Letter
Center classification date: Feb 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0490-2017, published Mar 8, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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