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Class II: temporary or reversible health riskTerminated

John W Hollis Mannitol 5% Solution for injection Recall

Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Inj…

John W Hollis Inc · Nashville, TN

Risk level
Class II
Reported by FDA
Jun 25, 2014
Recall ID
D-1394-2014
Check your lot numberHow we source this data

Summary

John W Hollis recalled Mannitol 5% Solution for injection starting May 12, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1394-2014 on Jun 25, 2014. Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Product description

Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Lot numbers, UPCs & expiration codes

Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14

Where it was sold

Nationwide

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-1394-2014
Classification
Class II
Status
Terminated
Recall initiated
May 12, 2014
FDA report date
Jun 25, 2014
Quantity
2250 mL
Recall type
Voluntary: Firm initiated
Recalling firm
John W Hollis Inc

Original FDA data

Every field from FDA enforcement report D-1394-2014, exactly as published.

Show all FDA fields
City
Nashville
State
TN
Status
Terminated
Country
United States
Event ID
68557
Address
110 20th Ave N
Code information
Lot 1507, Use by 5/18/14; Lot 1863, Use by 7/20/14
Postal code
37203-2315
Report date
Jun 25, 2014
Product type
Drugs
Recall number
D-1394-2014
Classification
Class II
Recalling firm
John W Hollis Inc
Product quantity
2250 mL
Termination date
Jul 2, 2014
Reason for recall
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Distribution pattern
Nationwide
Recall initiation date
May 12, 2014
Initial firm notification
Telephone
Center classification date
Jun 18, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1394-2014, published Jun 25, 2014. View the source record (openFDA) · FDA enforcement reports

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

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