CLASS II Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in vial recalled
Pharmalucence is recalling Kit for the Preparation of Technetium Tc99m Medronate, 20mg in vial, distributed nationwide in the US. The recall was initiated on 6 Jun 2018 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-1040-2018
- FDA event ID
- 80428
- Recalling firm
- Pharmalucence, Billerica, MA
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2018
- FDA classified
- 3 Aug 2018
- Reported
- 15 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jun 2018 | Recall initiated by company | |
| 3 Aug 2018 | Classified by FDA | +58 days |
| 15 Aug 2018 | Published in enforcement report | +12 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: Technetium TC-99M Medronate Kit has a reported breach 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
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Where it was distributed
Nationwide
Questions about this recall
Is Kit for the Preparation of Technetium Tc99m Medronate, 20mg in vial recalled?
Yes. Pharmalucence recalled Kit for the Preparation of Technetium Tc99m Medronate, 20mg in vial on 6 Jun 2018. The recall is Class II and its status is Terminated. Recall number D-1040-2018.
Why was it recalled?
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Which lots are affected?
Lot 4223
Where was it sold?
Nationwide
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 Pharmalucence
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg recalledKit For The Preparation Of Technetium Tc 99m Mebrofenin | Pharmalucence | Potency & Assay | Nationwide |
| Drug | CLASS III | Kit for the Preparation of Technetium Tc 99m Sestamibi recalled | Pharmalucence | Particulate Matter | Nationwide |