CLASS II Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report
Clindamycin Injection recalled by Alvogen
Alvogen is recalling Clindamycin Injection USP, distributed nationwide in the US. The recall was initiated on 16 Jun 2017 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-0941-2017
- FDA event ID
- 77545
- Recalling firm
- Alvogen, Pine Brook, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2017
- FDA classified
- 3 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 16 Jun 2017 | Recall initiated by company | |
| 3 Jul 2017 | Classified by FDA | +17 days |
| 12 Jul 2017 | Published in enforcement report | +9 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
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: 68-105-EV; Exp. 07/31/18, 68-106-EV; Exp. 07/31/18, and 73-157-EV; Exp. 12/31/18
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 77545This product is part of a recall event; the main page for the event is Clindamycin Injection recalled by Alvogen.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Clindamycin Injection recalled by Alvogen | Alvogen | Sterility | Nationwide | |
| CLASS II | Clindamycin Injection recalled by Alvogen | Alvogen | Sterility | Nationwide |
More recalls from Alvogen
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg recalled | Alvogen | Packaging Defects | Nationwide |
| Drug | CLASS I | Fentanyl Transdermal System CII, 25mcg/h recalled by AlvogenFentanyl System | Alvogen | Packaging Defects | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP 112 mcg recalled by Alvogen | Alvogen | Potency & Assay | Nationwide |
| Drug | CLASS II | Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg recalled by AlvogenBuprenorphine And Naloxone | Alvogen | Potency & Assay | Nationwide |
| Drug | CLASS II | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline | Alvogen | Potency & Assay | PR |
Other Clindamycin recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |