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Class II: temporary or reversible health riskTerminated

Fallon Wellness Pharmacy Methylcobolamin 1) 6500 mcg/0 Recall

Methylcobolamin 1) 6500 mcg/0

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

Risk level
Class II
Reported by FDA
May 20, 2015
Recall ID
D-1074-2015
Check your lot numberHow we source this data

Summary

Fallon Wellness Pharmacy recalled Methylcobolamin 1) 6500 mcg/0 starting Mar 17, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1074-2015 on May 20, 2015. Reason: Lack of assurance of sterility. Status: Terminated.

Why it was recalled

Lack of assurance of sterility

Product description

Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Lot numbers, UPCs & expiration codes

Lot#: a) 02052015@53, Exp 4/6/15; b) 01142015@31, Exp 3/15/15; c) 02022015@6, Exp 4/3/15; d) 01132015@72, Exp 3/14/15; e) 01282015@57, Exp 3/29/15; f) 01302015@50, Exp 3/31/15; g) 01232015@14, Exp 3/24/15

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-1074-2015
Classification
Class II
Status
Terminated
Recall initiated
Mar 17, 2015
FDA report date
May 20, 2015
Quantity
56 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Fallon Wellness Pharmacy, L.L.C.

Original FDA data

Every field from FDA enforcement report D-1074-2015, 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) 02052015@53, Exp 4/6/15; b) 01142015@31, Exp 3/15/15; c) 02022015@6, Exp 4/3/15; d) 01132015@72, Exp 3/14/15; e) 01282015@57, Exp 3/29/15; f) 01302015@50, Exp 3/31/15; g) 01232015@14, Exp 3/24/15
Postal code
12110-1002
Report date
May 20, 2015
Product type
Drugs
Recall number
D-1074-2015
Classification
Class II
Recalling firm
Fallon Wellness Pharmacy, L.L.C.
Product quantity
56 vials
Termination date
Jun 5, 2018
Reason for recall
Lack of assurance of sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL 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-1074-2015, published May 20, 2015. View the source record (openFDA) · FDA enforcement reports

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

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