Agency classClass IIOur severity:Severe FDA (Drugs)·D-1661-2015·Announced 2015-09-23

Vancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Vancomycin 25 mg/ml Ophthalmic Solution 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 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 recall is classified as FDA Class II and involves a sterile medical product where GMP violations impact sterility assurance, meeting the criteria for a Severe rating due to the potential for significant injury from non-sterile administration.

Plain-English summary

The Compounding Pharmacy of America is recalling Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen. The product is distributed nationwide in 28 ml quantities. The recall affects all lots distributed between November 2014 and May 2015, specifically including lot codes 03102015@34 (dated 6/8/2015) and 03042015@43 (dated 6/2/2015).

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations create a lack of assurance regarding the sterility of the product, potentially impacting its quality. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact The Compounding Pharmacy of America for further instructions or a return.

The recalled product

Product: Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Ophthalmic Solution
Hazard: sterility
gmp-violation

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)

All lots distributed between November 2014 and May 2015
03102015@34 6/8/2015
03042015@43
6/2/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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