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Class II: temporary or reversible health riskTerminated

The Apothecary Shoppe Tri-Mix 18/1/10 Recall

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged…

The Apothecary Shoppe LLC · Tulsa, OK

Risk level
Class II
Reported by FDA
Oct 12, 2016
Recall ID
D-0004-2017
Check your lot numberHow we source this data

Summary

The Apothecary Shoppe recalled Tri-Mix 18/1/10 starting Sep 12, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0004-2017 on Oct 12, 2016. Reason: Lack of Assurance of Sterility; medication was sterilized with a recalled filter. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Product description

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

Lot numbers, UPCs & expiration codes

07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016

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-0004-2017
Classification
Class II
Status
Terminated
Recall initiated
Sep 12, 2016
FDA report date
Oct 12, 2016
Quantity
247.5 mL total volume
Recall type
Voluntary: Firm initiated
Recalling firm
The Apothecary Shoppe LLC

Original FDA data

Every field from FDA enforcement report D-0004-2017, exactly as published.

Show all FDA fields
City
Tulsa
State
OK
Status
Terminated
Country
United States
Event ID
75212
Address
6136 E 51st St
Code information
07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016
Postal code
74135-7704
Report date
Oct 12, 2016
Product type
Drugs
Recall number
D-0004-2017
Classification
Class II
Recalling firm
The Apothecary Shoppe LLC
Product quantity
247.5 mL total volume
Termination date
Jan 25, 2018
Reason for recall
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Voluntary / mandated
Voluntary: Firm initiated
Product description
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Distribution pattern
Oklahoma
Recall initiation date
Sep 12, 2016
Initial firm notification
Telephone
Center classification date
Oct 4, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0004-2017, published Oct 12, 2016. View the source record (openFDA) · FDA enforcement reports

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

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