Lanthanum carbonate chewable tablets recalled after failing a hardness specification
Cipla USA is recalling Lanthanum Carbonate chewable tablets, 1000mg, after the product failed stability specifications with an out of specification hardness test result.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."
Plain-English summary
Lanthanum Carbonate chewable tablets, 1000mg, supplied as 10 x 9 bottles per patient pack carton, are being recalled. The prescription product is manufactured by Invagen Pharmaceuticals, Inc., a subsidiary of Cipla Ltd, of Hauppauge, New York, for Exelan Pharmaceuticals, Inc. of Boca Raton.
The recall follows failed stability specifications: an out of specification result on the hardness test.
The recall covers lot NB240314, expiry 12/31/2025. The record does not state a quantity. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
The record describes a stability testing failure rather than a reported patient harm. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific pack is affected.
The recalled product
- Product
- Deep-brand PREMIUM Select Jamun KEEP FROZEN Net Wt. 12 oz. (340 g)
- Manufacturer
- CHETAK NEW YORK LLC
- Category
- Drug — Phosphate binder
- Affected units
- 3,509,532
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 (14)
- Lots: 24355
- 24359
- 25004
- 25060
- 25067
- 25080
- 25101
- 25123
- 25139
- 25141
- 25144
- 25150
- 25157
- 25191
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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