Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Moisture Limits
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Affected NDC
0904-5833-15
Compare with the code on your package — it is the most precise check available.
Drug: Ephedrine Category: Allergy & Cold Medication
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 |
|---|---|---|---|---|
| Loratadine and Pseudoephedrine Sulfate NDC 00904-5833 |
LORATADINE 10 mg/1; PSEUDOEPHEDRINE SULFATE 240 mg/1 | Tablet, Film Coated, Extended Release Oral |
Major Pharmaceuticals | OTC |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 0904-5833-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0068-2022 · 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 Ephedrine recalls
See all
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Ephedrine Sulfate Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Ephedrine Plus
cGMP deviations
Other recalls by Sun Pharmaceutical Industries INC
All 2021 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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