Ferring Recalls TEV-TROPIN Injection Due to Potential Silicone Oil Contamination
Ferring Pharmaceuticals is recalling TEV-TROPIN injection bottles due to potential silicone oil contamination from a leaking line during manufacturing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a 'High' severity score when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Ferring Pharmaceuticals Inc is recalling 129,060 cartons of TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottles. The product is distributed by Gate Pharmaceuticals, a division of Teva Pharmaceuticals USA, in Sellersville, PA.
The recall was initiated because the medication may contain silicone oil due to leakage from a line during the freeze-drying process. The affected lots include H11599A, H11599B, H12913A, H12913B, H12914A, H12914B, H13846A, and H13846B, with expiration dates ranging from March 2016 to July 2016.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46
- Manufacturer
- Ferring Pharmaceuticals Inc
- Category
- Drug — Injectable Medication
- Affected units
- 129,060
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 (9)
- Lot # H11599A
- Exp. 03/16 Lot # H11599B
- Exp. 03/16 Lot # H12913A
- Exp. 05/16 Lot # H12913B
- Exp. 05/16 Lot # H12914A
- Exp. 05/16 Lot # H12914B
- Exp. 05/16 Lot # H13846A
- Exp. 07/16 Lot # H13846B
- Exp. 07/16
Distribution
Distributed in 1 state:
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