Sun Pharmaceutical Recalls Ganirelix Acetate Injection Due to Impurities
Sun Pharmaceutical Industries is recalling 91,211 syringes of Ganirelix Acetate Injection because the product failed impurities and degradation specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 91,211 syringes of Ganirelix Acetate Injection, 250 mcg/0.5 mL, sterile prefilled syringe. The product is distributed by Ferring Pharmaceuticals, Inc., and is manufactured in India. The recall is limited to the state of New Jersey.
The recall was initiated because the product failed impurities and degradation specifications. The affected lots are JKU1212A, JKU1503A, JKU1504A, JKU1505A, and JKU1506A with an expiration date of 03/2021, and lots JKU3313A and JKU3314A with an expiration date of 08/2021.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injection
- Hazard
- Affected units
- 91,211
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 (8)
- Lots JKU1212A
- JKU1503A
- JKU1504A
- JKU1505A
- JKU1506A
- Exp 03/2021
- JKU3313A & JKU3314A
- Exp 08/2021.
Distribution
Distributed in 1 state:
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