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Class II: temporary or reversible health riskTerminated

Health Innovations Pharmacy Baclofen 20 mg/4 mL Susp Recall

Baclofen 20 mg/4 mL Susp

Health Innovations Pharmacy, Inc · Southern Pines, NC

Risk level
Class II
Reported by FDA
May 20, 2015
Recall ID
D-1024-2015
Check your lot numberHow we source this data

Summary

Health Innovations Pharmacy recalled Baclofen 20 mg/4 mL Susp starting Feb 12, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1024-2015 on May 20, 2015. Reason: Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Product description

Baclofen 20 mg/4 mL Susp., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

NC

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-1024-2015
Classification
Class II
Status
Terminated
Recall initiated
Feb 12, 2015
FDA report date
May 20, 2015
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Health Innovations Pharmacy, Inc

Original FDA data

Every field from FDA enforcement report D-1024-2015, exactly as published.

Show all FDA fields
City
Southern Pines
State
NC
Status
Terminated
Country
United States
Event ID
70656
Address
295 Pinehurst Ave Bldg 2
Code information
All lots
Postal code
28387-7051
Report date
May 20, 2015
Product type
Drugs
Recall number
D-1024-2015
Classification
Class II
Recalling firm
Health Innovations Pharmacy, Inc
Termination date
Jul 20, 2017
Reason for recall
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Baclofen 20 mg/4 mL Susp., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Distribution pattern
NC
Recall initiation date
Feb 12, 2015
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 8, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1024-2015, 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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