The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0057-2018·Announced 2017-11-08

Precision Dose Recalls Subpotent Carbamazepine Oral Suspension Unit Dose Cups

Precision Dose Inc. is recalling Carbamazepine Oral Suspension USP unit dose cups because they tested below the required potency specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. A score of 2 is assigned to reflect the subpotent nature of the drug, which is a minor labeling or quality error rather than a high-risk contamination.

Plain-English summary

Precision Dose Inc. is recalling Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59 and NDC 68094-301-62). The recall involves 801 cases of the product, which is distributed nationwide in the USA. The specific lot number is 500105, with an expiration date of 04/30/18.

The recall was initiated because the product yielded low out-of-specification results, indicating that the drug is subpotent. This means the medication may not contain the full amount of the active ingredient required to be effective.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The recall is classified as Class III by the FDA, which indicates that the violation is not likely to cause adverse health consequences.

The recalled product

Product
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Manufacturer
Precision Dose Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
801

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 number: 500105
  • Exp 04/30/18

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Precision Dose Inc.

See all →

Same hazard · subpotent drug

See all →

Similar recalls