SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML — Class II drug recall D-1618-2012
Terminated recall by Franck's Lab Inc., d.b.a. Franck's Compounding Lab, reported 2012-08-22, distributed nationwide. Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed be
| Recall number | D-1618-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL, United States |
| Recall initiated | 2012-05-21 |
| Classified | 2012-08-10 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, DO, GT, KY, PL, VE |
| Quantity | 24 units |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
Product
SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE 0.9% (25X10ML) INJ. SDPF **** 0.9% INJECTABLE 25 VIAL 40 ML; SODIUM CHLORIDE (STERILE) 23.4% (20MEQ/5ML) SOLUTION 1000 ML 2500 ML; SODIUM CHLORIDE 0.9% BACTERIOSTATIC ** 0.9% INJECTABLE 30 MLS 750 ML; SODIUM CHLORIDE 0.9% IRRIGATION (24X250ML)** 0.9% SOLUTION 250 ML; SODIUM CHLORIDE 0.9%, 100ML I.V. BAG** 0.9% INJECTABLE 100 ML; SODIUM TETRADECYL SO4 3% INJECTABLE 20 ML; SODIUM TETRADECYL SULFATE 0.2 % INJECTABLE 30 ML (20 DIFFERENT PRODUCTS)
Reason for recall
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1618-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.