The Recall Desk
SevereFDA (Drugs)·D-1124-2022·Announced 2022-06-01

Benzonatate 100mg Capsules Label Mix-up — Wrong Medication in Bottles

Benzonatate 100mg capsule bottles are mislabeled. Some contain Benzphetamine tablets instead, and vice versa. This medication mix-up affects 10 bottles distributed to one physician in Alpharetta, Georgia.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I by the FDA, which requires a minimum severity score of 4. The label mix-up creates a medication safety hazard, as patients could receive an entirely different drug than prescribed. However, no illnesses or injuries have been reported as of the recall date.

Plain-English summary

Benzonatate 100mg capsules distributed by Calvin Scott & Company, Inc. (Albuquerque, NM) are subject to recall due to a labeling error. Bottles labeled as containing Benzonatate 100mg capsules actually contain Benzphetamine 50mg tablets, and vice versa, resulting in patients potentially receiving the wrong medication.

This product was distributed to one physician in Alpharetta, Georgia. Approximately 10 bottles are involved in this recall (lot CSI CS-20180W-004, expiration March 2022, NDC 67877-0573-05). Healthcare providers or patients who may have received this product should not use it. Patients and healthcare providers should contact Calvin Scott & Company, Inc., or their healthcare provider for guidance on the recall.

The recalled product

Product
Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Manufacturer
Calvin Scott & Company, Inc.
Category
Drug — Cough Suppressant / Appetite Suppressant
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • CSI Lot: CS-20180W-004
  • Exp 3/22

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Calvin Scott & Company, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Calvin Scott & Company, Inc.

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Same hazard · label mix up

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