Class II · Moderate risk
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Buspirone Hydrochloride Tabs USP 10 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
Affected NDCs
0615-7718-05
0615-7718-39
Compare with the code on your package — it is the most precise check available.
Drug: Iron
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Buspirone Hydrochloride NDC 00615-7718 |
10 mg/1 | Tablet Oral |
NCS HealthCare of KY, LLC dba Vangard Labs | Rx |
- Recalling firm
- NCS Healthcare of Kentucky Inc
- NDC code
- 0615-7718-05
- Origin
- KY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0113-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iron recalls
See all
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Venofer (iron sucrose)
Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk
Ferrous Sulfate Iron Supplement Drops
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by NCS Healthcare of Kentucky Inc
All 2023 recalls
Class III · Low risk
Lisinopril Tablets USP 20 mg
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk
Glycopyrrolate Tabs
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
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