Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0980-2016·Announced 2016-06-15

Well Care Compounding Pharmacy Recalls Atropine Sulfate Ophthalmic Drops

Well Care Compounding Pharmacy is recalling Atropine Sulfate 0.5% Ophthalmic Drops due to FDA inspection findings of GMP violations that may impact sterility.

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 involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Atropine Sulfate 0.5% Ophthalmic Drops. The product is packaged in 5mL droppers and is available by prescription only. The recall covers specific lots with expiration dates ranging from March 2016 to May 2016.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The source text does not report any illnesses or injuries associated with the use of these drops.

Consumers who have these specific products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The recall is limited to distribution in Nevada.

The recalled product

Product: ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Manufacturer: Well Care Compounding Pharmacy
Category: Drug — Ophthalmic
Hazard: sterility
gmp-violation
Affected units: 869

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 (8)

Lot #: 03252016:11 @26
Exp. 05/07/2016
Lot #: 04042016:28 @39
Exp. 05/06/2016
Lot #: 02102016:00 @22
Exp. 03/24/2016
Lot #:02112016:08 @13
Exp. 03/16/2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Well Care Compounding 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 51 products in this recall →

Same manufacturer · Well Care Compounding Pharmacy

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