Class II · Moderate risk
B6 (Pyridoxine HCl) for Injections
Lack of Assurance of Sterility
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Tablets/Capsules
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
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Affected NDC
69452-0206-20
Compare with the code on your package — it is the most precise check available.
Drug: Pyridoxine
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 |
|---|---|---|---|---|
| Doxylamine succinate and Pyridoxine hydrochloride NDC 69452-0206 |
DOXYLAMINE SUCCINATE 10 mg/1; PYRIDOXINE HYDROCHLORIDE 10 mg/1 | Tablet, Delayed Release Oral |
Bionpharma Inc., | Rx |
- Recalling firm
- Bionpharma Inc.
- NDC code
- 69452-206-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0822-2026 · 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.
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Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
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Class I · High risk
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Class II · Moderate risk
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Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
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