The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0487-2016·Announced 2015-12-09

FDA Recalls E3 Cream Compounded by Life Science Pharmacy Due to Penicillin Contamination

Life Science Pharmacy Inc. is recalling E3 Cream compounded in Harriman, NY, due to potential penicillin cross-contamination.

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 as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or potential for serious adverse health consequences (such as penicillin cross-contamination in a patient population) are categorized as Severe.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for E3 Cream, a prescription product compounded by Life Science Pharmacy Inc. in Harriman, NY. The recall is due to the potential for penicillin cross-contamination in the product.

The affected product is identified by Lot 02-11-15 14:44 Y and has an expiration date of 08/10/15. The distribution pattern is listed as nationwide. 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.

Consumers and healthcare providers should stop using the affected E3 Cream and contact their pharmacist or healthcare provider for further instructions. Individuals with a known penicillin allergy should exercise particular caution and seek medical advice if they have used the product.

The recalled product

Product
E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Manufacturer
Life Science Pharmacy Inc
Category
Drug — Compounded Prescription
Hazard

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: 02-11-15 14:44 Y
  • Exp Date: 08/10/15

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 →

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