Pharmakon Recalls Promethazine IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 725 units of compounded Promethazine IV bags due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a sterile medical product where sterility assurance is lacking is classified as Severe (Score 4) due to the potential for significant injury from non-sterile administration.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 725 units of Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag. The product is prescription-only and was compounded by Pharmakon in Noblesville, Indiana. The recall is being conducted due to a lack of assurance of sterility.
The affected products were distributed nationwide and to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.
Healthcare providers and patients should stop using the recalled product and contact Pharmakon Pharmaceuticals for further instructions or a replacement. The FDA has classified 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
- Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Compounded IV
- Hazard
- Affected units
- 725
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.
See all 88 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals, Inc.
See all →- SeverePharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Methohexital Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Ketamine Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- SeverePharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol
FDA (Drugs) · 2014-09-03
- HighNORepinephrine IV Bags Recalled for Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- SevereSCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
FDA (Drugs) · 2017-07-19
- HighFDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighFDA Recalls Heparin IV Bags Due to Lack of Sterility Validation
FDA (Drugs) · 2023-09-06
- HighPhenylephrine IV Bags Recalled for Sterility Assurance Deficiency
FDA (Drugs) · 2023-09-06