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.
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. 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
- Manufacturer
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Category
- Drug — Ophthalmic
- 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 →Related recalls
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