Severity
Moderate
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Reported: June 12, 2013 Initiated: May 2, 2013 #D-557-2013 43 vials of 250mL each units
THE COMPOUNDING SHOP, INC. issued this FDA Drug recall on June 12, 2013. Classified as Moderate severity (Class II). Approximately 43 vials of 250mL each units are affected. The recall was issued because: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Drug action (record #D-557-2013) was formally reported on June 12, 2013, with the manufacturer initiating the action on May 2, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. THE COMPOUNDING SHOP, INC. is listed as the recalling firm, operating out of St Petersburg, FL. Federal records indicate 43 vials of 250mL each units are affected.
The documented reason for this recall is: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Distribution data in the federal record shows the product reached: Florida, California, Minnesota, and Maine. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
43 vials of 250mL each
Related Recalls
6
0 from same agency
Product Description
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Details
- Recalling Firm
- THE COMPOUNDING SHOP, INC.
- Units Affected
- 43 vials of 250mL each
- Distribution
- Florida, California, Minnesota, and Maine
- Location
- St Petersburg, FL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-557-2013 |
| Date reported | June 12, 2013 |
| Date initiated | May 2, 2013 |
| Recalling firm | THE COMPOUNDING SHOP, INC. |
| Units affected | 43 vials of 250mL each |
| Distribution | Florida, California, Minnesota, and Maine |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL. Recalled by THE COMPOUNDING SHOP, INC.. Units affected: 43 vials of 250mL each.
Why was this product recalled? ▼
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-557-2013.
Where was the recalled product distributed? ▼
Distribution: Florida, California, Minnesota, and Maine.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-557-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).