Recall archive / FDA company announcement
Leiters, Compounding Health: Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags — FDA announcement Jan 8, 2024
Published notice; closure not supplied
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 Jan 8, 2024. 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
- Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags
- Reason
- Potential for superpotent drug
- Classification
- Not supplied
- Recalling firm
- Leiters Health
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- a5ce00242e4404e6
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Item # | Product Description | Lot # | Expiration; F3355 | FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag | 2331062 | 2/8/2024; 2331224 | 3/18/2024; 2331270 | 3/28/2024; F3342 | FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag | 2330988 | 1/31/2024; 2331058 | 2/18/2024; 2331150 | 3/10/2024; 2331231 | 3/24/2024; 2331289 | 3/30/2024; F3360 | Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag | 2330993 | 2/15/2024; 2331010 | 2/10/2024; 2331055 | 1/18/2024; 2331113 | 2/26/2024; 2331181 | 3/4/2024; 2331187 | 3/23/2024; 2331266 | 3/31/2024; 2331343 | 4/1/2024; 2331349 | 4/23/2024; 2331433 | 5/5/2024; F3352 | Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag | 2330939 | 1/30/2024; 2331032 | 2/3/2024; 2331112 | 3/19/2024; 2331190 | 3/26/2024; 2331429 | 4/28/2024; F3206 | Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag | 2331184 | 2/13/2024; 2331185 | 2/10/2024; 2331189 | 2/20/2024; 2331191 | 2/24/2024; 2331258 | 3/3/2024; 2331317 | 3/15/2024; F3208 | Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag | 2331140 | 2/8/2024; 2331188 | 2/15/2024; 2331261 | 3/5/2024; 2331287 | 3/14/2024 |
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.
| Item # | Product Description | Lot # | Expiration |
|---|---|---|---|
| F3355 | FentaNYL 1000 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 100 mL IV bag | 2331062 | 2/8/2024 |
| 2331224 | 3/18/2024 | ||
| 2331270 | 3/28/2024 | ||
| F3342 | FentaNYL 2500 mcg (10 mcg/mL) (as FentaNYL Citrate) PF (from API) added to 0.9% Sodium Chloride 250 mL IV bag | 2330988 | 1/31/2024 |
| 2331058 | 2/18/2024 | ||
| 2331150 | 3/10/2024 | ||
| 2331231 | 3/24/2024 | ||
| 2331289 | 3/30/2024 | ||
| F3360 | Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag | 2330993 | 2/15/2024 |
| 2331010 | 2/10/2024 | ||
| 2331055 | 1/18/2024 | ||
| 2331113 | 2/26/2024 | ||
| 2331181 | 3/4/2024 | ||
| 2331187 | 3/23/2024 | ||
| 2331266 | 3/31/2024 | ||
| 2331343 | 4/1/2024 | ||
| 2331349 | 4/23/2024 | ||
| 2331433 | 5/5/2024 | ||
| F3352 | Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% Sodium Chloride 250 mL IV Bag | 2330939 | 1/30/2024 |
| 2331032 | 2/3/2024 | ||
| 2331112 | 3/19/2024 | ||
| 2331190 | 3/26/2024 | ||
| 2331429 | 4/28/2024 | ||
| F3206 | Vancomycin HCl 1.25 g PF added to 0.9% Sodium Chloride 250 mL IV Bag | 2331184 | 2/13/2024 |
| 2331185 | 2/10/2024 | ||
| 2331189 | 2/20/2024 | ||
| 2331191 | 2/24/2024 | ||
| 2331258 | 3/3/2024 | ||
| 2331317 | 3/15/2024 | ||
| F3208 | Vancomycin HCl 1.5 g PF added to 0.9% Sodium Chloride 250 mL IV Bag | 2331140 | 2/8/2024 |
| 2331188 | 2/15/2024 | ||
| 2331261 | 3/5/2024 | ||
| 2331287 | 3/14/2024 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
The products were distributed nationwide to hospitals for administration in the hospital. Leiters Health has notified its customers by a letter sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have product which is being recalled should cease using it and return it to Leiters Health.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Jan 8, 2024
- Company announcement date
- Jan 5, 2024
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.