Dr. Reddy's Recalls Ranitidine Tablets Due to Microbial Contamination
Dr. Reddy's is recalling specific lots of OTC Ranitidine Hydrochloride tablets because raw material tested positive for Pseudomonas sp.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard like microbial contamination (Pseudomonas sp.) in a drug product warrants a 'Severe' rating (Score 4), particularly given the potential for serious injury or hospitalization associated with such pathogens.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling specific lots of Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC. The affected products include Equate brand Maximum Strength Acid Reducer (65 count), Equaline brand maximum strength heartburn relief, and Wal-Zan brand 150 Maximum Strength (24 count). These products were distributed nationwide by Wal-Mart Stores, Inc., Supervalu Inc., and Walgreen Co.
The recall was initiated because a lot of raw material used in the manufacture of the ranitidine was found to be positive for Pseudomonas sp. This indicates microbial contamination of the non-sterile product.
Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the retailer or manufacturer for a refund or replacement.
The recalled product
- 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…
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — OTC Antacid
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distributed nationwide across the United States.
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