Agency classClass IIOur severity:Severe FDA (Drugs)·D-457-2014·Announced 2014-01-22

Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns

Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.

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 lack of assurance of sterility for an injectable medication, which poses a significant risk of serious health consequences such as infection or sepsis.

Plain-English summary

Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Calcium Chloride PF 500 mg/mL prefilled syringes. The recall involves 8,090.8 mL of the prescription-only medication, which was manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers affected include 09202013@1 through 09202013@8, 10102013@7, 10102013@3, and 10102013@8.

The recall was initiated because the sterile compounded products were prepared in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled Calcium Chloride syringes cannot be assured. The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only.

Patients and healthcare providers should stop using the affected syringes and contact the recalling firm or their healthcare provider for further instructions. The U.S. Food and Drug Administration has classified this as a Class II recall.

The recalled product

Product: Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Manufacturer: Specialty Medicine Compounding Pharmacy
Category: Drug — Injectable Sterile Compounded
Hazard: lack-of-sterility
infection-risk

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 (13)

All unexpired lots
manufactured and distributed between 07/01/2013 and 10/19/2013
including Lot #s: 09202013@1
09202013@2
09202013@3
09202013@4
09202013@5
09202013@6
09202013@7
09202013@8
10102013@7
10102013@3
10102013@8

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 51 recalled by Specialty Medicine 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 · Specialty Medicine Compounding Pharmacy

See all →

Severe
Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns
FDA (Drugs) · 2014-01-22
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FDA (Drugs) · 2014-01-22
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Hyaluronidase Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2014-01-22
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Phenol Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
Severe
Cyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-22

Same hazard · lack of sterility