Life Science Pharmacy Recalls BI-EST Gels Due to Penicillin Contamination
Life Science Pharmacy Inc. is recalling BI-EST Gels because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.
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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury risks such as allergic reactions to penicillin.
Plain-English summary
Life Science Pharmacy Inc. is recalling BI-EST Gels, a prescription compounded product, due to potential cross-contamination with penicillin. The recall includes all lots of the product.
The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences. The contamination poses a risk to individuals with penicillin allergies.
Consumers who have purchased or been prescribed BI-EST Gels from Life Science Pharmacy Inc. should stop using the product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
- Manufacturer
- Life Science Pharmacy Inc
- Category
- Drug — Compounded Prescription
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 lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 recalled by Life Science Pharmacy 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 23 products in this recall →Related recalls
Same manufacturer · Life Science Pharmacy Inc
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Same hazard · penicillin contamination
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FDA (Drugs) · 2016-07-27
- SevereLife Science Pharmacy Recalls BI-EST Capsules Due to Penicillin Contamination
FDA (Drugs) · 2015-12-09
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