Agency classClass IIOur severity:High FDA (Drugs)·D-1487-2022·Announced 2022-09-14

Calcium Carbonate Oral Suspension Recalled Due to Manufacturing Control Deviations

Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—CGMP deviations in manufacturing—represents a risk of harm but remains theoretical without documented patient impact. Per the rubric, recalls with no reported illness and theoretical hazard score at most 3.

Plain-English summary

Plastikon Healthcare LLC is recalling Calcium Carbonate Oral Suspension, 1250 mg/5 mL, supplied in 5 mL cups (49,280 cups total). The product was packaged in trays for institutional use only and distributed nationwide throughout the United States.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations: manufacturing processes were not adequately controlled during production. Affected lot numbers include 21021A, 21023A, 21024A (exp. Feb. 2023); 21064A (exp. Jun. 2023); 21073A, 21075A (exp. Jul. 2023); 21100A (exp. Sep. 2023); 21118A, 21120A (exp. Nov. 2023); 21128A, 21129A, 21131A, 21135A (exp. Dec. 2023); and 22019A (exp. Mar. 2024).

Healthcare providers and patients should stop using affected lots. Consult a healthcare provider or Plastikon Healthcare LLC regarding alternative sources for calcium carbonate supplementation.

The recalled product

Product: CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
Manufacturer: Plastikon Healthcare LLC
Category: Drug
Hazard: cgmp-deviation
manufacturing-process-control-failure
Affected units: 49,280

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 (20)

Lot # 21021A
21023A
21024A
EXP Feb. 2023
21064A
EXP Jun. 2023
21073A
21075A
EXP Jul. 2023
21100A
EXP Sep. 2023
21118A
21120A
EXP Nov. 2023
21128A
21129A
21131A
21135A
EXP Dec. 2023
22019A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Plastikon Healthcare LLC 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 19 products in this recall →

Same manufacturer · Plastikon Healthcare LLC

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Same hazard · cgmp deviation