Recalls / Class I
Class ID-0058-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
- Brand name
- Octreotide Acetate
- Generic name
- Octreotide Acetate
- Active ingredient
- Octreotide Acetate
- Route
- Intravenous, Subcutaneous
- NDCs
- 67457-239, 67457-245, 67457-246
- FDA application
- ANDA079198
- Affected lot / code info
- Lot #: AJ21002, Exp. 03/2024
Why it was recalled
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Recalling firm
- Firm
- Viatris Inc
- Manufacturer
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, N/A, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 22400 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-10-07
- FDA classified
- 2022-11-08
- Posted by FDA
- 2022-11-16
- Terminated
- 2024-01-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0058-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.