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.
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 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
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