The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1855-2019·Announced 2019-09-18

Compounded Acetyl-L-Cysteine Eye Drops Recalled for Processing Control Issues

Compounded Solutions in Pharmacy is recalling 5% Acetyl-L-Cysteine Ophthalmic Solutions due to a lack of processing controls. The product was dispensed to patients in 5ml and 10ml dropper bottles.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a lack of processing controls rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Compounded Solutions in Pharmacy is recalling 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 5ml and 10ml dropper bottles. The recall is due to a lack of processing controls. The affected lots include specific expiration dates ranging from June 25, 2019, to August 31, 2019.

The product was dispensed to patients. The source text does not specify the geographic distribution or the number of units affected. No illnesses or injuries are reported in the provided text.

Patients who have received this product should contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Manufacturer
Compounded Solutions in Pharmacy
Category
Drug — Ophthalmic
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 (4)

  • Lots a) 07182019@29 exp: 8/31/19
  • 07082019@2 exp: 8/31/19
  • 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19
  • b) 07022019@28 exp: 8/31/19

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Compounded Solutions in 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 →

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