The Recall Desk
SevereFDA (Drugs)·D-0090-2019·Announced 2018-10-31

Westlab Pharmacy Recalls ADAA Cataract Drops Due to Process Control Issues

Westlab Pharmacy is recalling 222 syringes of ADAA Cataract Drops nationwide due to a lack of process controls.

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. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.

Plain-English summary

Westlab Pharmacy, Inc. is voluntarily recalling 222 syringes of ADAA Cataract Drops. The product is a 1cc syringe containing Lidocaine 1.47%, Phenylephrine 0.294%, Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxifloxacin 0.0294%, and Ketorolac 0.0147%. The specific lot number is 06182018@30 with an expiration date of 08/28/2018.

The recall was initiated due to a lack of process controls. The FDA has classified this recall as Class II, which indicates 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.

The affected product was distributed nationwide. Consumers who have this specific lot of ADAA Cataract Drops should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
Affected units
222

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: 06182018@30 Exp. 08/28/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Westlab Pharmacy, Inc. dba Westlab 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 3 products in this recall →

Same manufacturer · Westlab Pharmacy, Inc. dba Westlab Pharmacy

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