FDA Recalls Compounded Penile Injection Drugs Due to Insanitary Conditions
Professional Compounding Pharmacy is recalling compounded papaverine-phenolamine-PGE1 injections due to insanitary conditions observed during an FDA inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the severity rubric, FDA Class II recalls with potential for adverse health consequences due to processing failures are categorized as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for compounded papaverine-phenolamine-PGE1 22-0.8 mg-8 mcg/mL injectable solutions. The product is a penile injection available in 5 mL, 10 mL, and 6 mL vials. The recall is being conducted by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy, located in Corvallis, Oregon.
The recall was initiated because of a lack of processing controls and insanitary conditions observed during the compounding of sterile drugs during a recent FDA inspection. The affected products were dispensed in Oregon between September 1, 2018, and February 20, 2019. A total of 64 prescriptions were involved in the distribution of these specific lots.
Patients who have received these injections should contact their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
- Category
- Drug — Compounded Sterile Drug
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 (20)
- Lot: (a) 18092018@52
- 01102018@9
- 05102018@36
- 08102018@11
- 102018@9
- 03102018@27
- 12102018@18
- 17102018@15
- 2102018@18
- 22102018@31
- 30102018@22
- 29102018@9
- 29102018@9 29102018@9
- 21112018@38
- 11122018@7
- 28122018@11
- 03012019@17
- 08012019@21
- 28082018@16 28082018@16
- 28082018@16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 25 recalled by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy 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.
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