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Class II: temporary or reversible health riskTerminated

Chen Shwezin, Inc. dba Park Compounding Pharmacy Methylcobalamin 1000mcg/Ml Recall

METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N

Chen Shwezin, Inc. dba Park Compounding Pharmacy · Westlake Village, CA

Risk level
Class II
Reported by FDA
Nov 4, 2015
Recall ID
D-0157-2016
Check your lot numberHow we source this data

Summary

Chen Shwezin, Inc. dba Park Compounding Pharmacy recalled Methylcobalamin 1000mcg/Ml starting Oct 6, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0157-2016 on Nov 4, 2015. Reason: Lack of Assurance of Sterility: all sterile compounded products within expiry. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: all sterile compounded products within expiry

Product description

METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258

Lot numbers, UPCs & expiration codes

Lot#: 09102015@6, Exp 3/8/16

Where it was sold

CA

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-0157-2016
Classification
Class II
Status
Terminated
Recall initiated
Oct 6, 2015
FDA report date
Nov 4, 2015
Quantity
2 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Chen Shwezin, Inc. dba Park Compounding Pharmacy

Original FDA data

Every field from FDA enforcement report D-0157-2016, exactly as published.

Show all FDA fields
City
Westlake Village
State
CA
Status
Terminated
Country
United States
Event ID
72402
Address
280 N Westlake Blvd Ste 100
Code information
Lot#: 09102015@6, Exp 3/8/16
Postal code
91362-7014
Report date
Nov 4, 2015
Product type
Drugs
Recall number
D-0157-2016
Classification
Class II
Recalling firm
Chen Shwezin, Inc. dba Park Compounding Pharmacy
Product quantity
2 vials
Termination date
Nov 27, 2015
Reason for recall
Lack of Assurance of Sterility: all sterile compounded products within expiry
Voluntary / mandated
Voluntary: Firm initiated
Product description
METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
Distribution pattern
CA
Recall initiation date
Oct 6, 2015
Initial firm notification
Telephone
Center classification date
Oct 28, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0157-2016, published Nov 4, 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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