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Class II: temporary or reversible health riskTerminated

CMC Enterprise Pharmacy Phenylephrine 40 mg in 0 Recall

Phenylephrine 40 mg in 0

CMC Enterprise Pharmacy · Charlotte, NC

Risk level
Class II
Reported by FDA
May 1, 2019
Recall ID
D-1232-2019
Check your lot numberHow we source this data

Summary

CMC Enterprise Pharmacy recalled Phenylephrine 40 mg in 0 starting Apr 12, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1232-2019 on May 1, 2019. Reason: Lack of sterility assurance. Status: Terminated.

Why it was recalled

Lack of sterility assurance.

Product description

Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Lot numbers, UPCs & expiration codes

Lots: ED041912 Exp. 4/13/2019; ED051912 Exp. 4/14/2019; ED081912 Exp. 4/17/2019; ED091911 Exp. 4/18/2019; ED101912 Exp. 4/19/2019; ED111910 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-1232-2019
Classification
Class II
Status
Terminated
Recall initiated
Apr 12, 2019
FDA report date
May 1, 2019
Quantity
215 bags
Recall type
Voluntary: Firm initiated
Recalling firm
CMC Enterprise Pharmacy

Original FDA data

Every field from FDA enforcement report D-1232-2019, 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: ED041912 Exp. 4/13/2019; ED051912 Exp. 4/14/2019; ED081912 Exp. 4/17/2019; ED091911 Exp. 4/18/2019; ED101912 Exp. 4/19/2019; ED111910 Exp. 4/20/2019
Postal code
28208-5968
Report date
May 1, 2019
Product type
Drugs
Recall number
D-1232-2019
Classification
Class II
Recalling firm
CMC Enterprise Pharmacy
Product quantity
215 bags
Termination date
Oct 30, 2019
Reason for recall
Lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, 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-1232-2019, 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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