The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1062-2013·Announced 2013-10-02

CorePharma Recalls Pyridostigmine Bromide Tablets Due to Stability Failure

CorePharma is recalling 960 bottles of Pyridostigmine Bromide Tablets 60 mg because stability testing showed out-of-specification results.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 II, which typically corresponds to a moderate severity where the probability of serious adverse health consequences is remote, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

CorePharma, LLC is recalling 960 bottles of Pyridostigmine Bromide Tablets 60 mg, USP. The product is identified by NDC 64720-128-10, lot number 109497, and an expiration date of 12/15. The recall was initiated because the tablets failed stability specifications during testing, resulting in an out-of-specification test result.

The affected product was distributed nationwide. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or return. The recall is limited to the specific lot and expiration date listed above.

The recalled product

Product
Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Manufacturer
Core Pharma Llc
Category
Drug — Prescription Medication
Hazard
Affected units
960

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)

  • 109497
  • Exp. 12/15

Distribution

Distributed nationwide across the United States.

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