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Class II: temporary or reversible health riskTerminated

Fallon Wellness Pharmacy Hydroxocobalamin 1) 1000mcg/mL Recall

Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0

Fallon Wellness Pharmacy, L.L.C. · Latham, NY

Risk level
Class II
Reported by FDA
May 20, 2015
Recall ID
D-1075-2015
Check your lot numberHow we source this data

Summary

Fallon Wellness Pharmacy recalled Hydroxocobalamin 1) 1000mcg/mL starting Mar 17, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1075-2015 on May 20, 2015. Reason: Lack of assurance of sterility. Status: Terminated.

Why it was recalled

Lack of assurance of sterility

Product description

Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Lot numbers, UPCs & expiration codes

Lot#: a) 02092015@59, Exp 4/10/15; b) 02122015@49, Exp 4/13/15; c) 02132015@44, Exp 4/14/15; d) 02192015@34, Exp 4/20/15

Where it was sold

New York

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-1075-2015
Classification
Class II
Status
Terminated
Recall initiated
Mar 17, 2015
FDA report date
May 20, 2015
Quantity
70 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fallon Wellness Pharmacy, L.L.C.

Original FDA data

Every field from FDA enforcement report D-1075-2015, exactly as published.

Show all FDA fields
City
Latham
State
NY
Status
Terminated
Country
United States
Event ID
70807
Address
1057 Troy Schenectady Rd
Code information
Lot#: a) 02092015@59, Exp 4/10/15; b) 02122015@49, Exp 4/13/15; c) 02132015@44, Exp 4/14/15; d) 02192015@34, Exp 4/20/15
Postal code
12110-1002
Report date
May 20, 2015
Product type
Drugs
Recall number
D-1075-2015
Classification
Class II
Recalling firm
Fallon Wellness Pharmacy, L.L.C.
Product quantity
70 vials
Termination date
Jun 5, 2018
Reason for recall
Lack of assurance of sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Distribution pattern
New York
Recall initiation date
Mar 17, 2015
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 12, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1075-2015, published May 20, 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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