Eagle Pharmacy Recalls Subpotent Lipo B Sterile Injection Vials
Eagle Pharmacy is recalling 104 vials of Lipo B Sterile Injection due to trace amounts of methylcobalamin. The product was distributed in Alabama and Tennessee.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product might cause temporary or medically reversible adverse health consequences. The hazard is a subpotent drug, which fits the criteria for a High severity rating as it involves a risk of harm where the product does not perform as intended, though no specific injuries are reported in the source text.
Plain-English summary
Eagle Pharmacy, Inc. is recalling 104 vials of Lipo B Sterile Injection 10 mL. The recall is due to the presence of trace amounts of methylcobalamin in the compounded drug, which renders the product subpotent. The affected product is a prescription-only multidose vial containing methionine, inositol, choline chloride, pyridoxine hydrochloride, methylcobalamin, benzyl alcohol, sterile water, sodium hydroxide, and hydrochloric acid.
The recalled product is identified by Lot # 07072015LIPO and has an expiration date of 12/15. The distribution pattern for these vials includes Alabama and Tennessee. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact Eagle Pharmacy, Inc. for further instructions or a refund. This recall is being conducted to ensure the safety and efficacy of the compounded medication.
The recalled product
- Product
- LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy…
- Manufacturer
- Eagle Pharmacy, Inc.
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 104
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 (2)
- Lot # 07072015LIPO
- Exp. 12/15
Distribution
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