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Class II: temporary or reversible health riskTerminated

Central Admixture Pharmacy Services PHENYLephrine added to 0 Recall

PHENYLephrine added to 0

Central Admixture Pharmacy Services, Inc. · Allentown, PA

Risk level
Class II
Reported by FDA
May 31, 2023
Recall ID
D-0724-2023
Check your lot numberHow we source this data

Summary

Central Admixture Pharmacy Services recalled PHENYLephrine added to 0 starting Apr 28, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0724-2023 on May 31, 2023. Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Product description

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.

Lot numbers, UPCs & expiration codes

Lot # 37-883910, Exp 05/02/2023; 37-884221, Exp 05/03/2023; 37-884756, Exp 05/05/2023; 37-885358, Exp 05/08/2023; 37-885683, Exp 05/09/2023; 37-886267, 37-886268, Exp 05/11/2023; 37-886539, Exp 05/14/2023; 37-887458, 37-887459, Exp 05/16/2023; 37-888080, Exp 05/18/2023; 37-889192, Exp 05/23/2023; 37-889575, 37-889578, Exp 05/24/2023; 37-889852, 37-889855, Exp 05/25/2023; 37-890120, 37-890126, Exp 05/28/2023; 37-891485, 37-891491, Exp 06/01/2023; 37-892901, 37-892966, Exp 06/07/2023; 37-893236, 37-893237, Exp 06/08/2023; 37-893997, Exp 06/12/2023; 37-894777, Exp 06/14/2023; 37-895317, 37-895321, 37-895323, Exp 06/18/2023; 37-896201, Exp 06/20/2023; 37-896923, Exp 06/22/2023; 37-898558, Exp 06/29/2023

Where it was sold

Nationwide in the USA.

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-0724-2023
Classification
Class II
Status
Terminated
Recall initiated
Apr 28, 2023
FDA report date
May 31, 2023
Quantity
14205 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Central Admixture Pharmacy Services, Inc.

Original FDA data

Every field from FDA enforcement report D-0724-2023, exactly as published.

Show all FDA fields
City
Allentown
State
PA
Status
Terminated
Country
United States
Event ID
92253
Address
6580 Snowdrift Rd Ste 100
Code information
Lot # 37-883910, Exp 05/02/2023; 37-884221, Exp 05/03/2023; 37-884756, Exp 05/05/2023; 37-885358, Exp 05/08/2023; 37-885683, Exp 05/09/2023; 37-886267, 37-886268, Exp 05/11/2023; 37-886539, Exp 05/14/2023; 37-887458, 37-887459, Exp 05/16/2023; 37-888080, Exp 05/18/2023; 37-889192, Exp 05/23/2023; 37-889575, 37-889578, Exp 05/24/2023; 37-889852, 37-889855, Exp 05/25/2023; 37-890120, 37-890126, Exp 05/28/2023; 37-891485, 37-891491, Exp 06/01/2023; 37-892901, 37-892966, Exp 06/07/2023; 37-893236, 37-893237, Exp 06/08/2023; 37-893997, Exp 06/12/2023; 37-894777, Exp 06/14/2023; 37-895317, 37-895321, 37-895323, Exp 06/18/2023; 37-896201, Exp 06/20/2023; 37-896923, Exp 06/22/2023; 37-898558, Exp 06/29/2023
Postal code
18106-9331
Report date
May 31, 2023
Product type
Drugs
Recall number
D-0724-2023
Classification
Class II
Recalling firm
Central Admixture Pharmacy Services, Inc.
Product quantity
14205 bags
Termination date
Jun 22, 2025
Reason for recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.
Distribution pattern
Nationwide in the USA.
Recall initiation date
Apr 28, 2023
Initial firm notification
E-Mail
Center classification date
May 19, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0724-2023, published May 31, 2023. View the source record (openFDA) · FDA enforcement reports

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

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