Agency classClass IIOur severity:Severe FDA (Drugs)·D-1002-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Diltiazem Injection Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling Diltiazem 125 mg injection bags because they were made with recalled saline bags that may leak, compromising 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 the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

SCA Pharmaceuticals is recalling 120 bags of Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container. The product is prescription-only and was distributed nationwide in the USA. The specific lot number is 20170707@54, with a beyond-use date of October 4, 2017.

The recall was initiated due to a lack of assurance of sterility. The Diltiazem product was manufactured using 0.9% sodium chloride bags that were previously recalled because they have the potential to leak. This defect in the source material creates a risk that the final product may not be sterile.

Healthcare providers and patients should check their inventory for the specific NDC 70004-0541-35 and lot number 20170707@54. If the product is found, it should be quarantined and not administered. SCA Pharmaceuticals can be contacted at (877) 550-5059 for further instructions.

The recalled product

Product: Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
leakage
Affected units: 120

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 (2)

Lot: 20170707@54
BUD: 10/4/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by SCA Pharmaceuticals 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 6 products in this recall →

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