Recall archive / FDA company announcement

Mylan Institutional LLC: Octreotide Acetate Injection, 500 mcg/mL — FDA announcement Oct 25, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Oct 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Octreotide Acetate Injection, 500 mcg/mL
Reason: Due to glass particulates
Classification: Not supplied
Recalling firm: Mylan Institutional LLC, a Viatris company
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: d0e675e955473ee8

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – PITTSBURGH, October 25, 2022- Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass particles in a syringe.; This lot was manufactured by Italfarmaco SpA, Italy and was distributed by Mylan Institutional LLC in the US between January 11 and June 21, 2022. The recalled lot is as follows:; Risk Statement: Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low. To date, no reports of adverse reactions associated with this lot have been received.; Action: The company has initiated the recall of lot AJ21002 and notified its distributors by letter/phone and is arranging for return of all recalled products. Following are actions for wholesalers and retailers/users (hospitals/pharmacies):; Wholesalers: Immediately examine your inventory, quarantine and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to [email protected] within 5 business days. Sedgwick will notify your retail level customers that received the affected batches.; Retailers/Users (Hospitals/Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot.; Immediately examine your inventory, quarantine, and discontinue distribution of this lot.; NDC # \| Name and Strength \| Size \| Lot# \| Expiry; 67457-246-00 (Syringe) 67457-246-01 (Carton) \| Octreotide Acetate Injection 500 mcg/mL \| 10 X 1 mL Single dose unit-of-use Syringe \| AJ21002 \| March 2024

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – PITTSBURGH, October 25, 2022- Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass particles in a syringe.; This lot was manufactured by Italfarmaco SpA, Italy and was distributed by Mylan Institutional LLC in the US between January 11 and June 21, 2022. The recalled lot is as follows:; Risk Statement: Intravenous administration of a solution containing particulate matter, such as a glass, could lead to events including, but not limited to, local irritation or swelling, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. Although the intravenous administration of a solution containing particulate matter may pose potential risk of serious adverse events, the probability of exposure from this incident and subsequent risk is low. To date, no reports of adverse reactions associated with this lot have been received.; Action: The company has initiated the recall of lot AJ21002 and notified its distributors by letter/phone and is arranging for return of all recalled products. Following are actions for wholesalers and retailers/users (hospitals/pharmacies):; Wholesalers: Immediately examine your inventory, quarantine and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to [email protected] within 5 business days. Sedgwick will notify your retail level customers that received the affected batches.; Retailers/Users (Hospitals/Pharmacies): Immediately examine your inventory, quarantine and discontinue distribution of this lot.; Immediately examine your inventory, quarantine, and discontinue distribution of this lot.; NDC # | Name and Strength | Size | Lot# | Expiry; 67457-246-00 (Syringe) 67457-246-01 (Carton) | Octreotide Acetate Injection 500 mcg/mL | 10 X 1 mL Single dose unit-of-use Syringe | AJ21002 | March 2024

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
NDC #	Name and Strength	Size	Lot#	Expiry
67457-246-00 (Syringe) 67457-246-01 (Carton)	Octreotide Acetate Injection 500 mcg/mL	10 X 1 mL Single dose unit-of-use Syringe	AJ21002	March 2024

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Oct 25, 2022
Company announcement date: Oct 25, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.