Drug product
Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34
D-884-2013
Product summary
- Event
- Event 65885
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-884-2013
Official wording
Reason: Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
Code information: a)Lot: 5055822, exp. 03/13; 5056317, exp. 03/15; and 5056507, exp. 04/15 b)Lot: 7956571C, exp. 04/15 c)Lot: 7956572A, exp. 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination