Class I · High risk
Benzonatate capsules
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Diethylpropion
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
Affected NDC
0527-1475-01
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Diethylpropion Hydrochloride NDC 00527-1475 |
25 mg/1 | Tablet Oral |
Lannett Company, Inc. | Rx · CIV |
- Recalling firm
- Calvin Scott & Company, Inc.
- NDC code
- 00527-1475-01
- Origin
- NM, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0009-2021 · 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 recalls by Calvin Scott & Company, Inc.
All 2020 recalls
Class III · Low risk
Benzphetamine tablets
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Other stability / shelf life recalls from 2020
All stability / shelf life recalls
Class II · Moderate risk
Phentermine
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Diethylpropion
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Class II · Moderate risk
Buprenorphine Transdermal System 5 mcg/hour
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Class II · Moderate risk
Elitek (rasburicase)
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
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