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Class II: temporary or reversible health riskTerminated

Pacific Compounding Pharmacy & Consultations Cefuroxime 10mg/mL INJ 0 Recall

Cefuroxime 10mg/mL INJ 0

Pacific Compounding Pharmacy & Consultations Inc · Stockton, CA

Risk level
Class II
Reported by FDA
Apr 10, 2019
Recall ID
D-1076-2019
Check your lot numberHow we source this data

Summary

Pacific Compounding Pharmacy & Consultations recalled Cefuroxime 10mg/mL INJ 0 starting Aug 23, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1076-2019 on Apr 10, 2019. Reason: Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper

Product description

Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

Lot numbers, UPCs & expiration codes

Lot # 07232018@15 BUD 9/6/18 (frozen)

Where it was sold

California

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-1076-2019
Classification
Class II
Status
Terminated
Recall initiated
Aug 23, 2018
FDA report date
Apr 10, 2019
Quantity
41.4 mL
Recall type
Voluntary: Firm initiated
Recalling firm
Pacific Compounding Pharmacy & Consultations Inc

Original FDA data

Every field from FDA enforcement report D-1076-2019, exactly as published.

Show all FDA fields
City
Stockton
State
CA
Status
Terminated
Country
United States
Event ID
82477
Address
312 Lincoln Ctr
Code information
Lot # 07232018@15 BUD 9/6/18 (frozen)
Postal code
95207-2627
Report date
Apr 10, 2019
Product type
Drugs
Recall number
D-1076-2019
Classification
Class II
Recalling firm
Pacific Compounding Pharmacy & Consultations Inc
Product quantity
41.4 mL
Termination date
Apr 27, 2023
Reason for recall
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Voluntary / mandated
Voluntary: Firm initiated
Product description
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Distribution pattern
California
Recall initiation date
Aug 23, 2018
Initial firm notification
Telephone
Center classification date
Apr 2, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1076-2019, published Apr 10, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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