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Class II: temporary or reversible health riskTerminated

CMC Enterprise Pharmacy Phenylephrine 20 mg NS 250 mL bag Recall

Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive,…

CMC Enterprise Pharmacy · Charlotte, NC

Risk level
Class II
Reported by FDA
May 1, 2019
Recall ID
D-1231-2019
Check your lot numberHow we source this data

Summary

CMC Enterprise Pharmacy recalled Phenylephrine 20 mg NS 250 mL bag starting Apr 12, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1231-2019 on May 1, 2019. Reason: Lack of sterility assurance. Status: Terminated.

Why it was recalled

Lack of sterility assurance.

Product description

Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Lot numbers, UPCs & expiration codes

Lots: ED051911 Exp. 4/14/2019; ED081911 Exp. 4/17/2019; ED091910 Exp. 4/18/2019; ED101911 Exp. 4/19/2019; ED111909 Exp. 4/20/2019

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-1231-2019
Classification
Class II
Status
Terminated
Recall initiated
Apr 12, 2019
FDA report date
May 1, 2019
Quantity
390 bags
Recall type
Voluntary: Firm initiated
Recalling firm
CMC Enterprise Pharmacy

Original FDA data

Every field from FDA enforcement report D-1231-2019, exactly as published.

Show all FDA fields
City
Charlotte
State
NC
Status
Terminated
Country
United States
Event ID
82620
Address
4400 Golf Acres Dr
Code information
Lots: ED051911 Exp. 4/14/2019; ED081911 Exp. 4/17/2019; ED091910 Exp. 4/18/2019; ED101911 Exp. 4/19/2019; ED111909 Exp. 4/20/2019
Postal code
28208-5968
Report date
May 1, 2019
Product type
Drugs
Recall number
D-1231-2019
Classification
Class II
Recalling firm
CMC Enterprise Pharmacy
Product quantity
390 bags
Termination date
Oct 30, 2019
Reason for recall
Lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Distribution pattern
NC
Recall initiation date
Apr 12, 2019
Initial firm notification
Letter
Center classification date
Apr 23, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1231-2019, published May 1, 2019. 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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