Agency classClass IIOur severity:Severe FDA (Drugs)·D-1634-2015·Announced 2015-09-23

Sodium Ascorbate Injection Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Sodium Ascorbate 500 mg/ml Injection 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 injectable product with potential sterility failures, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

The Compounding Pharmacy of America is recalling Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate. The recall involves 4,554 ml of the product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.

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 lack of assurance of sterility is the primary reason for the recall.

Healthcare providers and patients who have received this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product: Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable
Hazard: sterility-failure
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
04202015@78
7/19/2015
02242015@9
5/25/2015
03162015@75
6/14/2015
03312015@70
6/29/2015
04292015@87
7/28/2015
05042015@41
8/2/2015
04212015@16
7/20/2015
02242015@54
and 04222015@65
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

See all →

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Same hazard · sterility failure