Agency classClass IIOur severity:Severe FDA (Drugs)·D-1442-2015·Announced 2015-09-23

Ascorbic Acid Injectable Vials Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Ascorbic Acid 500 mg/ml Injectable Vials nationwide due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

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, which corresponds to a 'Severe' rating under the rubric for significant injury/property-damage reports or high-risk scenarios, though no specific injuries are reported in the text.

Plain-English summary

The Compounding Pharmacy of America is recalling Ascorbic Acid 500 mg/ml Injectable Vials, sterile multi-dose vials, distributed nationwide. The recall involves 2,923 mL of total volume across multiple lots distributed between November 2014 and May 2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency cited a lack of assurance of sterility as the primary reason for the action.

Healthcare providers and patients should stop using the affected vials and contact the recalling firm for further instructions. The specific lot codes affected are listed in the official recall documentation.

The recalled product

Product: Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
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 (18)

All lots distributed between November 2014 and May 2015
05052015@1
8/3/2015
03112015@4
6/9/2015
03122015@32
6/10/2015
03122015@90
03232015@6
6/21/2015
03272015@38
6/25/2015
04072015@21
7/6/2015
05112015@75
8/9/2015
04222015@9
7/21/2015

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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Same hazard · sterility