Piramal Critical Care, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2014–2021 · PA

Piramal Critical Care, Inc. has 3 FDA enforcement events on this register (3 product records) between 2014 and 2021: 3 drug; the busiest year was 2014 with 1.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
10 Sep 2021	Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41	Drug	Class II	1	Terminated
8 Jul 2019	Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-01	Drug	Class II	1	Terminated
7 Apr 2014	Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25.	Drug	Class II	1	Terminated

By type and class

Drug3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Piramal Critical Care, Inc. by year initiated.

Questions and answers

How many FDA recalls has Piramal Critical Care, Inc. had?

3 enforcement events (3 product records) on this register, 2014–2021: 3 drug.

Are any Piramal Critical Care, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Piramal Critical Care, Inc. recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.