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Class II: temporary or reversible health riskTerminated

The Apothecary Shoppe SIU-Prostaglandin E1 500 mcg/mL Injection Recall

SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Comp…

The Apothecary Shoppe LLC · Tulsa, OK

Risk level
Class II
Reported by FDA
Aug 12, 2015
Recall ID
D-1313-2015
Check your lot numberHow we source this data

Summary

The Apothecary Shoppe recalled SIU-Prostaglandin E1 500 mcg/mL Injection starting Jun 26, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1313-2015 on Aug 12, 2015. Reason: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Product description

SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135

Lot numbers, UPCs & expiration codes

Lot #: 05042015@33, BUD 10/31/2015; 03102015@45, 03112015@14, 03192015@42, BUD 09/01/2015

Where it was sold

Oklahoma

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-1313-2015
Classification
Class II
Status
Terminated
Recall initiated
Jun 26, 2015
FDA report date
Aug 12, 2015
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
The Apothecary Shoppe LLC

Original FDA data

Every field from FDA enforcement report D-1313-2015, exactly as published.

Show all FDA fields
City
Tulsa
State
OK
Status
Terminated
Country
United States
Event ID
71618
Address
6136 E 51st St
Code information
Lot #: 05042015@33, BUD 10/31/2015; 03102015@45, 03112015@14, 03192015@42, BUD 09/01/2015
Postal code
74135-7704
Report date
Aug 12, 2015
Product type
Drugs
Recall number
D-1313-2015
Classification
Class II
Recalling firm
The Apothecary Shoppe LLC
Termination date
Feb 17, 2017
Reason for recall
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Voluntary / mandated
Voluntary: Firm initiated
Product description
SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Distribution pattern
Oklahoma
Recall initiation date
Jun 26, 2015
Initial firm notification
Letter
Center classification date
Aug 6, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1313-2015, published Aug 12, 2015. View the source record (openFDA) · FDA enforcement reports

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

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