Recalls / Class II
Class IID-1348-2019
Product
Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
- Affected lot / code info
- Lot #s: a) 17E003; 17E038, Exp. 05/2019; 17F002; 17F005; 17F007; 17F025, Exp. 06/2019; 17G014, Exp. 07/2019; 17H015, Exp. 08/2019; 17J004; 17J006; 17J016, Exp. 09/2019; 17K008; 17K013; 17K021; 17K027, Exp. 10/2019; 17L021, Exp. 11/2019; 17M032, Exp. 12/2019; 18A023; 18A039, Exp. 01/2020; 18B007; 18B030; 18B037, Exp. 02/2020; 18C017; 18C026, Exp. 03/2020; 18D003; 18D034, Exp. 04/2020; 18E027; 18E033, Exp. 05/2020; 18F024; 18F033, Exp. 06/2020; 18G001; 18G023, Exp. 07/2020; 18J008; 18J009; 18J017; 18J027, Exp. 09/2020; 18K013; 18K014; 18K028, Exp. 10/2020. b) 17E006; 17E008, Exp. 05/2019; 17G001; 17G008;17G025, Exp. 07/2019; 17J022, Exp. 09/2019; 17K001; 17K007; 17K007A, Exp. 10/2019; 17L014, 17L034, Exp. 11/2019; 18A007; 18A007A, Exp. 01/2020; 18A025; 18A036, Exp. 01/2020; 18B018; 18B033; 18B034, Exp. 02/2020; 18D032; 18D035, Exp. 04/2020; 18E006; 18E035; 18E036, Exp. 05/2020; 18F033; 18F034, Exp. 06/2020; 18G007; 18G019, Exp. 07/2020; 18H008; 18H009; 18H025, Exp. 08/2020; 19A002, Exp. 01/2021.
Why it was recalled
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recalling firm
- Firm
- Torrent Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- 2,646,228 bottles
- Distribution pattern
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1348-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.