The Recall Desk
ModerateFDA (Drugs)·D-1317-2020·Announced 2020-06-10

Torrent Pharma Recalls Carbamazepine Tablets for Failed Dissolution Specifications

Torrent Pharma Inc. is recalling 6,228 bottles of Carbamazepine 200 mg tablets because they failed to meet dissolution specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is defined as a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a contamination or mislabeling of a common allergen.

Plain-English summary

Torrent Pharma Inc. is recalling 6,228 bottles of Carbamazepine Tablets, USP 200 mg. The product is packaged in 500-count bottles and is available by prescription only. The specific lot number is 4FF4F001, with an expiration date of 1/2023. The NDC for the recalled product is 13668-268-05.

The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the expected rate in the body. Failure to meet these specifications may result in the medication not working as intended.

The affected product was distributed nationwide in the United States and in Puerto Rico. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
CARBAMAZEPINE (CARBAMAZEPINE)
Brand
CARBAMAZEPINE
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
6,228

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)

  • Lot #: 4FF4F001
  • Exp 1/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same brand · CARBAMAZEPINE

Same manufacturer · Torrent Pharma Inc.

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Same hazard · failed dissolution

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