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Class II: temporary or reversible health riskTerminated

South Coast Specialty Compounding Leucovorin Calcium capsules Recall

Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA

South Coast Specialty Compounding, Inc. · Irvine, CA

Risk level
Class II
Reported by FDA
Sep 9, 2015
Recall ID
D-1338-2015
Check your lot numberHow we source this data

Summary

South Coast Specialty Compounding recalled Leucovorin Calcium capsules starting Apr 23, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1338-2015 on Sep 9, 2015. Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Status: Terminated.

Why it was recalled

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Product description

Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA

Lot numbers, UPCs & expiration codes

All Lots; Exp 06/15

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-1338-2015
Classification
Class II
Status
Terminated
Recall initiated
Apr 23, 2015
FDA report date
Sep 9, 2015
Quantity
2,355 capsules ( 26 presciptions)
Recall type
Voluntary: Firm initiated
Recalling firm
South Coast Specialty Compounding, Inc.

Original FDA data

Every field from FDA enforcement report D-1338-2015, exactly as published.

Show all FDA fields
City
Irvine
State
CA
Status
Terminated
Country
United States
Event ID
71078
Address
9257 Research Dr
Code information
All Lots; Exp 06/15
Postal code
92618-4286
Report date
Sep 9, 2015
Product type
Drugs
Recall number
D-1338-2015
Classification
Class II
Recalling firm
South Coast Specialty Compounding, Inc.
Product quantity
2,355 capsules ( 26 presciptions)
Termination date
May 31, 2016
Reason for recall
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
Distribution pattern
Nationwide.
Recall initiation date
Apr 23, 2015
Initial firm notification
Letter
Center classification date
Sep 2, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1338-2015, published Sep 9, 2015. 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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