FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Colonia Care Pharmacy C-Calcium Glucnate 1% Injection Soln Recall

C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 I…

Colonia Care Pharmacy · Colonia, NJ

Risk level
Class II
Reported by FDA
Oct 9, 2019
Recall ID
D-0007-2020
Check your lot numberHow we source this data

Summary

Colonia Care Pharmacy recalled C-Calcium Glucnate 1% Injection Soln starting Jul 24, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0007-2020 on Oct 9, 2019. Reason: Lack of Assurance of Sterility: product sterility cannot be guaranteed. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Product description

C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

Lot numbers, UPCs & expiration codes

Lot #: 071119C, BUD 08/25/19

Where it was sold

Patient Specific Prescriptions in NJ

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-0007-2020
Classification
Class II
Status
Terminated
Recall initiated
Jul 24, 2019
FDA report date
Oct 9, 2019
Quantity
1 vial
Recall type
Voluntary: Firm initiated
Recalling firm
Colonia Care Pharmacy

Original FDA data

Every field from FDA enforcement report D-0007-2020, exactly as published.

Show all FDA fields
City
Colonia
State
NJ
Status
Terminated
Country
United States
Event ID
83427
Address
515 Inman Ave Ste A
Code information
Lot #: 071119C, BUD 08/25/19
Postal code
07067-1114
Report date
Oct 9, 2019
Product type
Drugs
Recall number
D-0007-2020
Classification
Class II
Recalling firm
Colonia Care Pharmacy
Product quantity
1 vial
Termination date
Apr 5, 2023
Reason for recall
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Voluntary / mandated
Voluntary: Firm initiated
Product description
C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Distribution pattern
Patient Specific Prescriptions in NJ
Recall initiation date
Jul 24, 2019
Initial firm notification
Letter
Center classification date
Oct 1, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0007-2020, published Oct 9, 2019. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls