Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Class I - DangerousWhat Should You Do?
- Check if you have this product: 05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- The Apothecary Shoppe LLC
- Reason for Recall:
- Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Product Codes/Lot Numbers:
05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0003-2017
Related Recalls
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
The Apothecary Shoppe
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
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
The Apothecary Shoppe
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
The Apothecary Shoppe
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.