The Recall Desk
SevereFDA (Drugs)·D-1567-2019·Announced 2019-08-07

Wise Pharmacy Recalls Acetylcysteine Otic Drops Due to Processing Controls

Wise Pharmacy is recalling Acetylcysteine 2% Otic Drops due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.

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 FDA classified this recall as Class II, which corresponds to a Severe severity score under the rubric for drug recalls.

Plain-English summary

Wise Pharmacy, located in Littleton, Colorado, is recalling Acetylcysteine 2% Otic Drop, 15 mL bottles. The recall was initiated because of a lack of processing controls. The affected product is prescription-only and requires refrigeration.

The specific lot number is 7131N, with an expiration date of July 11, 2019. The product was distributed in Colorado, Texas, and Wyoming. The FDA has classified this recall as Class II.

Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Manufacturer
Wise Pharmacy
Affected units
1

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 #: 7131N
  • Exp 7/11/19

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 11 recalled by Wise Pharmacy 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 11 products in this recall →