FDARecalled May 31, 2023 · #D-0741-2023
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Classification: Class II Distribution: Nationwide in the USA.
Product details
- Product
- tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
- Type
- Drugs
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Model numbers
- 37-884580
- UPCs
- —