Ferring Recalls TEV-TROPIN Due to Needle-Free Head Labeling Error
Ferring Pharmaceuticals is recalling 126 injectors of TEV-TROPIN because the cartons are labeled for Needle-Free Head B but contain Needle-Free Head A.
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 is typically a score of 1 or 2. It is scored as 2 because it involves a labeling error on a prescription drug, which is a minor labeling error but potentially more significant than a cosmetic defect.
Plain-English summary
Ferring Pharmaceuticals Inc is recalling 126 injectors of TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). The recall involves Lot #201131320087, which expires in September 2015. The product is distributed nationwide by TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA.
The recall was initiated due to a labeling error. The units are packaged in cartons labeled for Needle-Free Head B, but they actually contain Needle-Free Head A. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact Ferring Pharmaceuticals or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel.
- Manufacturer
- Ferring Pharmaceuticals Inc
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 126
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 (1)
- LOT #201131320087 Exp 09/15
Distribution
Distributed nationwide across the United States.
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