The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category