Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Preferred Pharmaceuticals
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Out of specification results observed in dissolution during long term stability testing.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09
Affected NDC
68788-6390-09
Compare with the code on your package — it is the most precise check available.
Drug: Lansoprazole
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 |
|---|---|---|---|---|
| Lansoprazole NDC 68788-6390 |
15 mg/1 | Capsule, Delayed Release Oral |
Preferred Pharmaceuticals Inc. | Rx |
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-6390-09
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0769-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lansoprazole recalls
See all
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific…
CGMP Deviations: product held outside appropriate storage temperature conditions.
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All 2022 recalls
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Class II · Moderate risk
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Class II · Moderate risk
Ibuprofen Tablets
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