CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
Green Tea (EGCG) Injectable, 10mg/mL vial recalled by Downing Labs
Downing Labs is recalling Green Tea (EGCG) Injectable, 10mg/mL vial, distributed nationwide in the US. The recall was initiated on 16 Oct 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0361-2016
- FDA event ID
- 72455
- Recalling firm
- Downing Labs, Dallas, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2015
- FDA classified
- 18 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Oct 2015 | Recall initiated by company | |
| 18 Nov 2015 | Classified by FDA | +33 days |
| 25 Nov 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Where it was distributed
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Questions about this recall
Is Green Tea (EGCG) Injectable, 10mg/mL vial recalled?
Yes. Downing Labs recalled Green Tea (EGCG) Injectable, 10mg/mL vial on 16 Oct 2015. The recall is Class II and its status is Terminated. Recall number D-0361-2016.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots
Where was it sold?
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Downing Labs
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chromium Injectable, 200mg/mL vial recalled by Downing Labs | Downing Labs | Sterility | Nationwide |
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| Drug | CLASS II | Dexpanthenol Injection, 250mg/mL vial recalled by Downing Labs | Downing Labs | Sterility | Nationwide |
| Drug | CLASS II | M.I.C Injection (Preserved), 25/50/25mg/mL vial recalled by Downing Labs | Downing Labs | Sterility | Nationwide |
| Drug | CLASS II | Calcium Gluconate (680mOsm/L) Injection 10% vial recalled | Downing Labs | Sterility | Nationwide |