Recalls / Class II
Class IID-0914-2018
Product
RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
- Affected lot / code info
- Lots: 0113064 Exp. 03/2018, 0114628 Exp. 08/2018, 0115189 Exp. 08/2018, 0115462 Exp. 09/2018
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Mckesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd Nw, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 17,192 cartons (1,719,200 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-02-26
- FDA classified
- 2018-07-09
- Posted by FDA
- 2018-03-14
- Terminated
- 2020-09-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0914-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.