US Compounding Recalls Omnipaque 300 Vials Due to Sterility Concerns
US Compounding Inc is recalling 8,218 vials of Omnipaque 300 injection due to deficient practices that may impact sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is voluntarily recalling 8,218 vials of Omnipaque 300 (600 mg/2 mL), a prescription-only injectable medication. The product is distributed nationwide and is compounded by US Compounding Pharmacy in Conway, Arkansas.
The recall is being conducted because of deficient practices that may have an impact on the assurance of sterility for these preparations. The affected lots have expiration dates ranging from September 12, 2015, to December 26, 2015.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Affected units
- 8,218
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 (11)
- Lot Code: 20150604@4 BUD: 10/3/2015
- 20152205@1 BUD: 11/18/2015
- 20152303@3 BUD: 9/19/2015
- 20150604@1 BUD: 10/3/2015
- 20151304@27 BUD: 9/19/2015
- 20151506@19 BUD: 12/12/2015
- 20151506@27R BUD: 11/28/2015
- 20151603@2 BUD: 9/12/2015
- 20152004@13 BUD: 10/17/2015
- 20152206@13 BUD: 12/19/2015
- 20152906@7 BUD: 12/26/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding 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 59 products in this recall →Related recalls
Same manufacturer · US Compounding Inc
See all →- LowUS Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error
FDA (Drugs) · 2021-01-20
- LowUS Compounding Recalls Neostigmine Methylsulfate Syringes Due to Missing Labels
FDA (Drugs) · 2021-01-06
- SevereUS Compounding Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-02-27
- ModerateUS Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates
FDA (Drugs) · 2019-02-20
- SevereUS Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination
FDA (Drugs) · 2016-12-28
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereFDA Recalls Compounded Omnipaque Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- HighNew England Compounding Center Recalls Omnipaque Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereB-Complex Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereMontana Compounding Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-06-17
- SevereFDA Recalls Injectable Ascorbic Acid Vials Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Acetyl-L-Carnitine Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-09-23