Apothecary Shoppe Recalls Phenotolamine and Prostaglandin Vials Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling Phenotolamine 0.4mg/Prostaglandin 20mcg/mL vials because they were sterilized with a recalled filter, raising concerns about sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility assurance for an injectable medication) corresponds to a severity score of 4 (Severe).
Plain-English summary
The Apothecary Shoppe LLC is recalling Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials. The recall was initiated because the medication was sterilized using a filter that was itself subject to a recall. This raises a lack of assurance regarding the sterility of the product.
The affected product is a prescription medication intended for intramuscular (IM) use. The recall involves a total volume of 455 mL. Specific lot codes and beyond-use dates are identified in the recall notice, including lots manufactured in May, July, and August 2016.
The product was distributed in Oklahoma. The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Injectable Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 05162016@18 BUD 09/13/2016
- 07052016@9 BUD 11/02/2016
- 08032016@13 BUD 12/01/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by The Apothecary Shoppe LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · The Apothecary Shoppe LLC
See all →- SevereThe Apothecary Shoppe Recalls Tri-Mix 18/1/10 Due to Sterility Concerns
FDA (Drugs) · 2016-10-12
- SevereMethylcobalamin Injection Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2016-10-12
- ModerateApothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
FDA (Drugs) · 2015-08-12
- ModerateApothecary Shoppe Recalls SIU-Tri-Mix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-08-12
- ModerateApothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns
FDA (Drugs) · 2015-08-12
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22