Docusate Sodium Softgels Recalled Due to Incorrect Secondary Carton Labeling
Rx Pak Division of McKesson Corporation is recalling Docusate Sodium 100mg softgels because secondary cartons may be mislabeled as Gabapentin 300mg.
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 involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (mislabeling) rather than a contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Rx Pak Division of McKesson Corporation is recalling 29,622 blister cards of Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards for institutional use only. The product was manufactured by Aenova Holding GmBh, Miami, FL, and carries NDC 63739-0478-10. The specific lot affected is # 0119397, with an expiration date of 02/2020.
The recall was initiated due to a labeling error where the secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps. This mislabeling could lead to the wrong medication being dispensed or administered.
The product was distributed to 5 major distributors who may have further distributed the product throughout the United States. Institutions and healthcare providers should check their inventory for this specific lot and NDC number. If the product is found, it should be removed from use and returned to the distributor or the recalling firm.
The recalled product
- Product
- Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
- Manufacturer
- Rx Pak Division of McKesson Corporation
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 29,622
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 # 0119397
- Exp 02/2020
Distribution
Distribution scope not specified by the agency.
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