Pharmakon Recalls Provocholine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 142 units of Provocholine pre-diluted syringes nationwide due to a lack of assurance of sterility.
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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a drug product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 142 units of Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes. The affected products are prescription-only (Rx Only) and come in various concentrations, including 0.0625mg/mL, 0.25 mg/mL, 1 mg/mL, 4 mg/mL, and 16 mg/ml, each in 3 mL syringes. The products were compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify a particular pathogen or contamination event, but indicates that the sterility of the compounded products could not be guaranteed. The recall covers all sterile compounded products within their expiry dates.
The products were distributed nationwide, with specific distribution to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. Consumers and healthcare providers should stop using the affected syringes and contact Pharmakon Pharmaceuticals or their healthcare provider for further instructions.
The recalled product
- Product
- Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Sterile Compounded Drug
- Affected units
- 142
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 (1)
- All Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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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