Unique Pharmaceutical Recalls Repinephrine IV Bags Due to Sterility Concerns
Unique Pharmaceutical is recalling 430 bags of Repinephrine 4 mg in 250 mL Sodium Chloride 0.9% because a mold-like substance was found on an unopened bag during production.
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 (mold-like substance) in an intravenous product, which poses a risk of serious adverse health consequences such as infection.
Plain-English summary
Unique Pharmaceutical, Ltd is recalling 430 bags of Repinephrine 4 mg in 250 mL Sodium Chloride 0.9%, For IV Use Only. The product is identified by Lot # 00083844 with an expiration date of 07/13. The recall was initiated because a mold-like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while the bag was being prepped for production.
The recalled product was distributed to Tennessee, Pennsylvania, and Texas. 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, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients should stop using the affected product and contact their supplier or the recalling firm for instructions on return or disposal. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
- Manufacturer
- Unique Pharmaceutical, Ltd
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 430
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)
- Lot # 00083844 Exp. 07/13
Distribution
Related recalls
Same manufacturer · Unique Pharmaceutical, Ltd
See all →- CriticalUnique Pharmaceutical Recalls N-Acetyl Cysteine Vials Due to Non-Sterility
FDA (Drugs) · 2014-10-15
- SevereUnique Pharmaceutical Recalls Sterile Products Due to Sterility Assurance Issues
FDA (Drugs) · 2014-10-15
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29