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Class II: temporary or reversible health riskTerminated

Liberty Drug & Surgical Methylcobalamin 5000 mcg/mL Injectable Recall

Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Cente…

Liberty Drug & Surgical · Chatham, NJ

Risk level
Class II
Reported by FDA
Sep 2, 2015
Recall ID
D-1382-2015
Check your lot numberHow we source this data

Summary

Liberty Drug & Surgical recalled Methylcobalamin 5000 mcg/mL Injectable starting Jun 15, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1382-2015 on Sep 2, 2015. Reason: Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Product description

Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot numbers, UPCs & expiration codes

Lot #: 05152015@4, Exp 06/29/15

Where it was sold

Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

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-1382-2015
Classification
Class II
Status
Terminated
Recall initiated
Jun 15, 2015
FDA report date
Sep 2, 2015
Quantity
5 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Liberty Drug & Surgical

Original FDA data

Every field from FDA enforcement report D-1382-2015, exactly as published.

Show all FDA fields
City
Chatham
State
NJ
Status
Terminated
Country
United States
Event ID
71591
Address
195 Main St
Code information
Lot #: 05152015@4, Exp 06/29/15
Postal code
07928-2405
Report date
Sep 2, 2015
Product type
Drugs
Recall number
D-1382-2015
Classification
Class II
Recalling firm
Liberty Drug & Surgical
Product quantity
5 vials
Termination date
Apr 23, 2018
Reason for recall
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Distribution pattern
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Recall initiation date
Jun 15, 2015
Initial firm notification
Telephone
Center classification date
Aug 27, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1382-2015, published Sep 2, 2015. View the source record (openFDA) · FDA enforcement reports

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

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