The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1854-2019·Announced 2019-09-18

Compounded Acetyl-L-Cysteine Eye Drops Recalled for Lack of Processing Controls

Compounded Solutions in Pharmacy is recalling 10% Acetyl-L-Cysteine Ophthalmic Solutions due to a lack of processing 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 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Compounded Solutions in Pharmacy is recalling 10% Acetyl-L-Cysteine Ophthalmic Solutions, which are dispensed in 5ml, 10ml, and 15ml dropper bottles. The recall is being conducted because of a lack of processing controls.

The affected product was dispensed to patients. Specific lot numbers and expiration dates are listed in the official recall documentation.

Patients who have received this product should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, 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 (9)

  • Lots: a) 08012019@33 exp: 8/15/19
  • 07182019@66 exp: 8/01/19
  • 07182019@15 exp: 8/01/19
  • 07012019@46 exp. 08/31/19
  • 07082019@27 exp: 8/31/19
  • b) 07082019@55 exp: 8/31/19
  • 07182019@55 exp: 08/31/19
  • 06242019@55 exp: 8/31/19
  • 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19

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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