The Recall Desk
HighFDA (Drugs)·D-1385-2014·Announced 2014-06-25

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.

What this means for you

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
Hazard
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:

Related recalls

Same manufacturer · Ferring Pharmaceuticals Inc

See all →

Same hazard · chemical contamination

See all →